Page last updated: 2024-11-12

bismuth subsalicylate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

bismuth subsalicylate: bismuth subsalicylate is the active ingredient of Pepto-Bismol and in Kaopectate; used to treat nausea, heartburn, indigestion, upset stomach, diarrhea and other temporary discomforts of the stomach; used with Azoles and other drugs to treat Helicobacter [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

bismuth subsalicylate : A bismuth salt of salicylic acid. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID16682734
CHEBI ID261649
MeSH IDM0065203

Synonyms (73)

Synonym
MLS000069654
smr000059234
ccris 4751
vismut
spiromak forte
stabisol
bismutum subsalicylicum
salicylic acid, bismuth basic salt
wismutsalicylat, basisches
hsdb 332
bismuthi subsalicylas
bismuth salicylate, basic
salicylic acid basic bismuth salt
2-hydroxybenzoic acid bismuth (3+) salt, basic
bismuth, (2-hydroxybenzoato-o(1),o(2))oxo-
bismuth, oxo(salicylato)-
einecs 238-953-1
14882-18-9
bismuth subsalicylate
C07870
87-27-4
4h-1,3,2-benzodioxabismin-4-one, 2-hydroxy-
2-hydroxy-1,3,2-benzodioxabismin-4-one
bismuth(iii) subsalicylate, 99.9% trace metals basis
DB01294
NCGC00166299-01
basic bismuth salicylate
bismuth oxide salicylate
2-hydroxy-benzo[1,3,2]dioxabismin-4-one
bismuth oxysalicylate
pink bismuth
wismutsubsalicylat
D00728
pepto-bismol (tn)
bismuth subsalicylate (jan/usp)
bismuth, (2-hydroxybenzoato-o1,o2)oxo-
HMS2093H13
CHEBI:261649 ,
2-hydroxy-4h-1,3,2-benzodioxabismin-4-one
trigastronol
bismogenol tosse inj
unii-62tey51rr1
bismuth subsalicylate [usan:usp:jan]
nsc 759117
ec 238-953-1
tox21_112398
dtxcid004622
dtxsid6024622 ,
cas-14882-18-9
nsc759117
pharmakon1600-01505412
bismuth(iii) subsalicylate
AKOS015888405
CCG-213424
HY-B0550
NCGC00166299-03
AB00489978_02
mfcd00085368
2-hydroxy-2h,4h-benzo[d]1,3-dioxa-2-bismacyclohexan-4-one
bismuth(iii) salicylate basic, purum, >=97.0% (kt)
bismuth subsalicylate, united states pharmacopeia (usp) reference standard
SR-05000001933-1
sr-05000001933
AS-65783
wismutoxidsalicylat
J-008518
SBI-0206855.P001
2-hydroxy-4h-benzo[d][1,3,2]dioxabismin-4-one
bismuth oxysalicylate;bismuth(iii) salicylate basic
bismuth-subsalicylate
bismuth oxysalicylate, bismuth subsalicylate, bismuth(iii) salicylate basic
?bismuth subsalicylate
EN300-7869807

Research Excerpts

Overview

Bismuth subsalicylate (BSS) is a compound without significant aqueous solubility. It is widely used for the treatment of gastrointestinal disorders.

ExcerptReferenceRelevance
"Bismuth subsalicylate is a common constituent of over-the-counter medications for diarrhea. "( A controlled trial of bismuth subsalicylate in infants with acute watery diarrheal disease.
Campos-Sánchez, M; Eyzaguirre-Maccan, E; Figueroa-Quintanilla, D; León-Barúa, R; Sack, RB; Salazar-Lindo, E; Sarabia-Arce, S, 1993
)
2.04
"Bismuth subsalicylate (BSS) is a compound without significant aqueous solubility that is widely used for the treatment of gastrointestinal disorders. "( Binding and killing of bacteria by bismuth subsalicylate.
Olson, CA; Sox, TE, 1989
)
2

Effects

Bismuth subsalicylate has been used for more than 80 years to treat gastrointestinal symptoms. The effect of BSS in the form of nanoparticles (BSS-nano) as a potential antimicrobial agent has not been tested.

ExcerptReferenceRelevance
"Bismuth subsalicylate has an aspirin equivalency conversion factor of 0.479 (approximately half the strength of aspirin)."( Salicylate toxicity associated with administration of Percy medicine in an infant.
Badillo, R; Hagemann, TM; Lewis, TV; McGoodwin, L; Schaeffer, S, 2006
)
1.06
"Bismuth subsalicylate (BSS) has been used as an antimicrobial agent, but the effect of BSS in the form of nanoparticles (BSS-nano) as a potential antimicrobial agent has not been tested, in specific against bacteria responsible for periodontal disease."( Bismuth subsalicylate nanoparticles with anaerobic antibacterial activity for dental applications.
Almaguer-Flores, A; Aztatzi-Aguilar, OG; Camps, E; De Vizcaya-Ruiz, A; Flores-Castañeda, M; Uribe-Ramírez, M; Vega-Jiménez, AL, 2017
)
2.62
"Bismuth subsalicylate has been used for treatment of acute diarrhoea, with preliminary promising results."( Which place for bismuth subsalicylate in the treatment of enteric infections?
Bruzzese, E; Guarino, A, 2001
)
1.38
"Bismuth subsalicylate (BSS) has been used for more than 80 years to treat gastrointestinal symptoms although little clinical evidence was available until recently to substantiate its value and possible mechanisms of action. "( Bismuth subsalicylate in the treatment and prevention of diarrheal disease.
DuPont, HL, 1987
)
3.16

Treatment

Bismuth subsalicylate treatment was better than ranitidine at both four and at eight weeks. It is a safe and effective adjunct to oral rehydration therapy for infants and young children with acute watery diarrhea.

ExcerptReferenceRelevance
"Bismuth subsalicylate treatment for 8 weeks is safe and well tolerated. "( Efficacy of open-label bismuth subsalicylate for the treatment of microscopic colitis.
Fine, KD; Lee, EL, 1998
)
2.05
"Bismuth subsalicylate treatment was better than ranitidine at both four and at eight weeks (p less than 0.05)."( Bismuth subsalicylate in the treatment of H2 blocker resistant duodenal ulcers: role of Helicobacter pylori.
Bär, W; Freise, J; Gebel, M; Gladziwa, U; Haruma, K; Lange, P; Schmidt, FW; Wagner, S, 1992
)
2.45
"Treatment with bismuth subsalicylate and metronidazole resulted in symptomatic improvement in 61-66% of non-ulcer dyspepsia patients regardless of initial or post-treatment H."( Long-term follow-up of Helicobacter pylori treatment in non-ulcer dyspepsia patients.
Appelman, HD; Barnett, JL; Behler, EM; Crause, I; Elta, GH; Nostrant, TT; Scheiman, JM, 1995
)
0.63
"Treatment with bismuth subsalicylate decreases the duration of diarrhea and is a safe and effective adjunct to oral rehydration therapy for infants and young children with acute watery diarrhea."( A controlled trial of bismuth subsalicylate in infants with acute watery diarrheal disease.
Campos-Sánchez, M; Eyzaguirre-Maccan, E; Figueroa-Quintanilla, D; León-Barúa, R; Sack, RB; Salazar-Lindo, E; Sarabia-Arce, S, 1993
)
0.95

Toxicity

ExcerptReferenceRelevance
" The general public may assume that over-the-counter products are safe because they do not require a prescription."( Salicylate toxicity associated with administration of Percy medicine in an infant.
Badillo, R; Hagemann, TM; Lewis, TV; McGoodwin, L; Schaeffer, S, 2006
)
0.33
"To establish the efficiency and adverse effects of the addition of bismuth subsalicylate to triple eradication therapy for Helicobacter pylori infection."( [Addition of bismuth subsalicylate to triple eradication therapy for Helicobacter pylori infection: efficiency and adverse events].
Díaz Ferrer, J; Hinostroza Morales, D,
)
0.74
" The adverse events of both groups were: diarrhea (10."( [Addition of bismuth subsalicylate to triple eradication therapy for Helicobacter pylori infection: efficiency and adverse events].
Díaz Ferrer, J; Hinostroza Morales, D,
)
0.5
" This case highlights the potential adverse effects of over-the-counter medications."( Salicylate toxicity from chronic bismuth subsalicylate use.
Halani, S; Wu, PE, 2020
)
0.84

Bioavailability

Ciprofloxacin bioavailability will not be significantly decreased by single doses of bismuth subsalicylate when the two medications are administered simultaneously.

ExcerptReferenceRelevance
" Bioavailability of doxycycline was significantly reduced by 37% and 51%, respectively, when subsalicylate bismuth was given simultaneously and as a multiple-dose regimen before doxycycline."( Influence of subsalicylate bismuth on absorption of doxycycline.
Cleary, TG; Ericsson, CD; Feldman, S; Pickering, LK, 1982
)
0.26
" For other otherwise healthy persons, poorly absorbed agents are preferable in order to avoid the serious, albeit rare, toxicity of systemic drugs."( Prevention and treatment of traveler's diarrhea: a clinical pharmacological approach.
Rampal, P; Scarpignato, C, 1995
)
0.29
" These results suggest that ciprofloxacin bioavailability will not be significantly decreased by single doses of bismuth subsalicylate when the two medications are administered simultaneously."( Effect of bismuth subsalicylate on ciprofloxacin bioavailability.
Gallicano, K; Garber, G; Oliveras, L; Rambout, L; Sahai, J, 1994
)
0.9
"To determine whether the observed decrease in tetracycline bioavailability is due to the active drug bismuth subsalicylate via complexation, or to magnesium aluminum silicate (Veegum), an inactive excipient present only in the liquid formulation of bismuth subsalicylate, which might adsorb the tetracycline, rendering it unavailable for systemic absorption."( Reduced tetracycline bioavailability caused by magnesium aluminum silicate in liquid formulations of bismuth subsalicylate.
Clendening, CE; Dansereau, RJ; Deepe, GS; Dunn, AB; Healy, DP; Mounts, AW, 1997
)
0.73
" With the advent of poorly absorbed (<0."( Current and future developments in travelers' diarrhea therapy.
DuPont, HL; Koo, HL, 2006
)
0.33
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

Bismuth subsalicylate (Pepto-Bismol) taken orally at a dosage of as low as 30 ml every half hour for eight doses was shown to be effective in reducing the frequently of episodes of diarrhea.

ExcerptRelevanceReference
"Twelve healthy male subjects were dosed with six regimens: ranitidine and De-Noltab (tripotassium dicitrato bismuthate; Gist-Brocades Ltd."( The effect of histamine H2-receptor blockade on bismuth absorption from three ulcer-healing compounds.
Hudson, M; Nwokolo, CU; Pounder, RE; Prewett, EJ; Sawyerr, AM, 1991
)
0.28
" The dosing regimen was 20 mg/kg five times daily for 5 days."( Bismuth subsalicylate in the treatment of acute diarrhea in children: a clinical study.
Avendaño, P; Balm, TK; Braun, SD; Manhart, MD; O'Ryan, M; Soriano, HA; Soriano-Brücher, H, 1991
)
1.72
" It proved possible to reduce the oral prednisolone dosage from a median of 15 mg/day (range 10 to 35 mg/day) to 6 mg/day (range 0 to 18 mg/day) after 8 weeks of treatment; 5 patients were no longer taking oral steroids at this time."( Rectal bismuth subsalicylate as therapy for ulcerative colitis.
Jones, H; Rhodes, JM; Ryder, SD; Walker, RJ, 1990
)
0.73
" Of three dosage regimens tested, continuous treatment before and after the bacterial challenge, mimicking the way BSS is used in the prevention of traveller's diarrhoea, was the most effective."( Bismuth subsalicylate in the prevention of colonization of infant mice with Campylobacter jejuni.
Hänninen, ML, 1990
)
1.72
" Extended dosing of Pepto-Bismol (3."( Bismuth subsalicylate: history, chemistry, and safety.
Bierer, DW,
)
1.57
" Patients received either BSS at a dosage of 100 mg/(kg."( Use of bismuth subsalicylate in acute diarrhea in children.
Avendaño, P; O'Ryan, M; Soriano, HA; Soriano-Brücher, HE,
)
0.59
" In the first study, 62 subjects received BSS for 3 weeks at a dosage of 60 mL four times daily (4."( Use of bismuth subsalicylate for the prevention of travelers' diarrhea.
de la Cabada, FJ; DuPont, HL; Ericsson, CD; Johnson, PC,
)
0.59
"025), bismuth subsalicylate (Pepto-Bismol) taken orally at a dosage of as low as 30 ml every half hour for eight doses was shown to be effective in reducing the frequently of episodes of diarrhea."( Nonantibiotic therapy for travelers' diarrhea.
DuPont, HL; Ericsson, CD; Johnson, PC,
)
0.61
" The dosage of two tablets of bismuth subsalicylate four times daily (2."( Prevention of travelers' diarrhea by the tablet formulation of bismuth subsalicylate.
Bitsura, JA; de la Cabada, FJ; DuPont, HL; DuPont, MW; Ericsson, CD; Johnson, PC, 1987
)
0.8
" Treatment was given for 7 days with dosage varied according to age."( Bismuth subsalicylate in the treatment of chronic diarrhea of childhood.
Grill, B; Gryboski, JD; Hillemeier, AC; Kocoshis, S, 1985
)
1.71
"The efficacy of a daily dosage regimen of subsalicylate bismuth in preventing or reducing the severity of diarrhea among young healthy adults was evaluated in a double-blind, randomized, placebo-controlled trial."( Prevention of traveler's diarrhea (emporiatric enteritis). Prophylactic administration of subsalicylate bismuth).
Ackerman, PB; DuPont, HL; Ericsson, CD; Evans, DG; Evans, DJ; Pickering, LK; Sullivan, P; Tjoa, WS; Vollet, JJ, 1980
)
0.26
"-azithromycin dosage regime (83%) (95% CI = 52-98%) compared to the 250-mg-b."( Azithromycin triple therapy for Helicobacter pylori infection: azithromycin, tetracycline, and bismuth.
al-Assi, MT; Cole, RA; Genta, RM; Graham, DY; Karttunen, TJ, 1995
)
0.29
" Other factors reported to affect compliance included the frequency of dosing and the number of pills."( A randomized controlled trial of an enhanced patient compliance program for Helicobacter pylori therapy.
Canning, A; Egan, C; Farraye, FA; Kemp, JA; Lee, M; Tataronis, G, 1999
)
0.3
"We evaluated the effect of optimized doses and dosing schedules of metronidazole, tetracycline, and bismuth-metronidazole-tetracycline (BMT) triple therapy with only 1 day of dosing on Helicobacter pylori SS1 titers in a mouse model."( Effects of metronidazole, tetracycline, and bismuth-metronidazole-tetracycline triple therapy in the Helicobacter pylori SS1 mouse model after 1 day of dosing: development of an H. pylori lead selection model.
Amsler, KM; Foster, LA; Merrill, JJ; Modzelewski, TC; Quispe, JD; Sizemore, CF; Slee, AM; Stevenson, DA, 2002
)
0.31
"Pediatricians in Africa requested a tool to improve caregiver dosing of liquid antiretroviral medication."( Design, evaluation, and dissemination of a plastic syringe clip to improve dosing accuracy of liquid medications.
Adler, M; Dinh, C; Gray, LV; Gutierrez, A; Lu, B; Lukomnik, J; Marton, S; Mirabal, Y; Oden, M; Richards-Kortum, R; Schutze, GE; Shah, K; Slough, T; Spiegel, GJ; Wickham, H; Yeh, PT, 2013
)
0.39
" DMF was dosed twice-daily (BID) at 120 mg (week 1) and 240 mg (weeks 2-8)."( Effect of Bismuth Subsalicylate on Gastrointestinal Tolerability in Healthy Volunteers Receiving Oral Delayed-release Dimethyl Fumarate: PREVENT, a Randomized, Multicenter, Double-blind, Placebo-controlled Study.
Chalkias, S; Edwards, MR; Koulinska, I; Riester, K, 2018
)
0.88
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Protein Targets (5)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, TYROSYL-DNA PHOSPHODIESTERASEHomo sapiens (human)Potency19.32180.004023.8416100.0000AID485290; AID489007
LuciferasePhotinus pyralis (common eastern firefly)Potency40.53340.007215.758889.3584AID624030
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency3.16230.035520.977089.1251AID504332
lamin isoform A-delta10Homo sapiens (human)Potency0.05010.891312.067628.1838AID1487
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency0.39080.009610.525035.4813AID1479145
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Ceullar Components (1)

Processvia Protein(s)Taxonomy
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (4)

Assay IDTitleYearJournalArticle
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (354)

TimeframeStudies, This Drug (%)All Drugs %
pre-199081 (22.88)18.7374
1990's143 (40.40)18.2507
2000's65 (18.36)29.6817
2010's47 (13.28)24.3611
2020's18 (5.08)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 67.82

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index67.82 (24.57)
Research Supply Index6.22 (2.92)
Research Growth Index4.62 (4.65)
Search Engine Demand Index176.91 (26.88)
Search Engine Supply Index3.00 (0.95)

This Compound (67.82)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials93 (22.85%)5.53%
Reviews62 (15.23%)6.00%
Case Studies50 (12.29%)4.05%
Observational0 (0.00%)0.25%
Other202 (49.63%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (22)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
THE EFFECT OF HELICOBACTER PYLORI ERADICATION THERAPY TO GASTRIC WALL THICKNESS BEFORE THE LAPAROSCOPIC SLEEVE GASTRECTOMY [NCT03757650]Phase 43 participants (Actual)Interventional2018-10-01Completed
Efficacy of One Dose of Laxative on Post-Operative Constipation Following Total Knee Arthroplasty [NCT04380090]Phase 2154 participants (Actual)Interventional2020-02-21Completed
Effect of Prunes on Gastrointestinal Function After Gynecological Surgery: A Randomized Controlled Trial [NCT03523715]Phase 477 participants (Actual)Interventional2017-11-30Terminated(stopped due to Difficulty in recruiting participants)
Treatment of Non-Anemic Iron Deficiency in Pregnancy: a Double-Blind Randomized Control Trial [NCT05423249]150 participants (Anticipated)Interventional2022-08-12Recruiting
Interventions to Decrease the Impact of Post-Operative Ileus After Liver Transplant or Resection Surgery [NCT01156129]Phase 1111 participants (Actual)Interventional2010-09-01Completed
An Exploratory Study of The Effect of Bismuth Subsalicylate on The Gut Microbiome and Host Response in Healthy Adults [NCT05930197]Phase 130 participants (Anticipated)Interventional2023-08-31Recruiting
Randomized, Double-Blind, Placebo-Controlled Trial of Oral Docusate for Preventing/Treating Constipation in Palliative Care Patients. [NCT00902031]70 participants (Anticipated)Interventional2006-04-30Completed
A Multicenter, Double Blind, Placebo-Controlled Study of Pepto-Bismol® (Bismuth Subsalicylate) on Gastrointestinal Tolerability in Healthy Volunteers Receiving Oral TECFIDERA™ (Dimethyl Fumarate) Delayed-Release Capsules Twice Daily [NCT01915901]Phase 1175 participants (Actual)Interventional2013-08-31Completed
Randomized, Double-blind, Placebo-controlled Trial of the Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients in Pakistan [NCT02047162]400 participants (Actual)Interventional2014-05-31Completed
RELISTOR's Effects on Opioid-Induced Constipation in Postoperative 1-2 Level Anterior Lumbar Interbody Fusion Patients: A Case-Control Study [NCT04930237]0 participants (Actual)Observational2021-07-01Withdrawn(stopped due to PI request to close study)
CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA [NCT00002682]Phase 25 participants (Actual)Interventional1995-08-10Completed
[NCT01481844]Phase 3101 participants (Actual)Interventional2011-11-30Completed
A Multi-center, Randomized, Single-blind Clinical Study of the Comparative Safety and Efficacy of Docusate Sodium and Sorbitol Rectal Solution and Glycerine Enemas in Patients With Constipation [NCT01474499]Phase 3300 participants (Actual)Interventional2011-09-30Completed
Can Use of Bismuth Subsalicylate in Clostridium Difficile Patients Decrease the Length of Stay and Time to Resolution of Symptoms [NCT03592082]Phase 40 participants (Actual)Interventional2018-03-01Withdrawn(stopped due to Investigator left institution)
[NCT01742429]Phase 4200 participants (Actual)Interventional2012-11-30Completed
The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient [NCT01773096]Phase 460 participants (Anticipated)Interventional2013-05-31Completed
Comparing the Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population [NCT04348786]Phase 478 participants (Actual)Interventional2019-02-01Completed
Pilot Study for the Efficacy and Tolerability of Senokot-S in the Treatment of Diabetic Gastroparesis [NCT03342157]Phase 22 participants (Actual)Interventional2018-04-02Terminated(stopped due to low enrollment)
Pilot and Randomized, Controlled Studies to Assess Stool Frequency of COVID + Patients Treated With Oral Bismuth Subsalicylate (Pepto-Bismol): SABER-C and Lite-SABER-C (Specific Administration of Bismuth for Early Recovery of COVID-19) [NCT04811339]Phase 460 participants (Actual)Interventional2020-10-27Completed
Impact of Naloxegol on Prevention of Lower GI Tract Paralysis in Critically Ill Adults Initiated on Scheduled Intravenous Opioid Therapy: A Randomized, Double-Blind, Placebo-Controlled, Phase II, Single-Center, Proof of Concept Study [NCT02977286]Phase 412 participants (Actual)Interventional2017-01-01Terminated(stopped due to Poor enrollment)
Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial [NCT01044212]72 participants (Actual)Interventional2009-11-30Completed
Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea and Impact on Acquisition of Gut Antimicrobial Resistance Genes [NCT03535272]Phase 3482 participants (Anticipated)Interventional2018-05-20Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01044212 (3) [back to overview]Time to First Post-op Bowel Movement
NCT01044212 (3) [back to overview]Consistency of First Postoperative Bowel Movement
NCT01044212 (3) [back to overview]Pain Level Associated With First Postoperative Bowel Movement
NCT02977286 (17) [back to overview]Daily Presence of Delirium Using the Intensive Care Delirium Screening Checklist (ICDSC)
NCT02977286 (17) [back to overview]Days Without Mechanical Ventilation Support for Duration of ICU Stay
NCT02977286 (17) [back to overview]ICU Days Without a SBM
NCT02977286 (17) [back to overview]Number of Patients That Required Use of the Study Laxative Protocol
NCT02977286 (17) [back to overview]Number of Patients With Loose and Unformed or Liquid SBM
NCT02977286 (17) [back to overview]Occurrence of Lower GI Tract Paralysis (≥3 Days Without a SBM)
NCT02977286 (17) [back to overview]Occurrence of Lower GI Tract Paralysis Requiring GI/Surgical Consultation
NCT02977286 (17) [back to overview]Percentage of Daily Goal Reached for Enteral Nutrition Administration
NCT02977286 (17) [back to overview]Time to First Episode of Diarrhea
NCT02977286 (17) [back to overview]Time to First Spontaneous Bowel Movement (SBM)
NCT02977286 (17) [back to overview]Time to First Spontaneous Bowel Movement (SBM) Administration
NCT02977286 (17) [back to overview]Abdominal Pressure Measurement
NCT02977286 (17) [back to overview]Average Daily Opioid Requirement [in IV Fentanyl Equivalents (mcg Per Day)]
NCT02977286 (17) [back to overview]Daily Difference in the Pre-dose and Post-dose Clinical Opioid Withdrawal Scale (COWS) Score
NCT02977286 (17) [back to overview]Daily Fluid Balance
NCT02977286 (17) [back to overview]Daily Maximal Pain Scale Score
NCT02977286 (17) [back to overview]Daily Maximal Sedation Assessment Scale (SAS) Score
NCT03523715 (7) [back to overview]Bowel Movement in the Study Period
NCT03523715 (7) [back to overview]Pain With Bowel Movement Measured
NCT03523715 (7) [back to overview]Requirements for Laxatives
NCT03523715 (7) [back to overview]Satisfaction With Bowel Regimen
NCT03523715 (7) [back to overview]Satisfaction With Surgery Overall
NCT03523715 (7) [back to overview]Stool Consistency of the First Bowel Movement
NCT03523715 (7) [back to overview]Time to First Bowel Movement
NCT04380090 (4) [back to overview]Laxative Use Within 3 Days of Surgery
NCT04380090 (4) [back to overview]Opioid Use Within 3 Days of Surgery
NCT04380090 (4) [back to overview]Straining With BM
NCT04380090 (4) [back to overview]Bowel Movement (BM) Within 3 Days of Surgery
NCT04811339 (3) [back to overview]Day 3 Composite 3 Symptom Score
NCT04811339 (3) [back to overview]Measure of Daily Stool Frequency for Patients With COVID Treated With Bismuth
NCT04811339 (3) [back to overview]Day 3 Composite 5 Symptom Score

Time to First Post-op Bowel Movement

The time to first post-operative bowel movement was measured in hours after surgery. (NCT01044212)
Timeframe: Within 1 week of surgery

Interventionhours (Mean)
Bowel Medications64
Docusate Controls77

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Consistency of First Postoperative Bowel Movement

"The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol_stool_scale.~The seven types of stool are:~Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid" (NCT01044212)
Timeframe: Within 1 week of surgery

InterventionBristol Stool Scale (Mean)
Bowel Medications3.13
Docusate Controls3.40

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Pain Level Associated With First Postoperative Bowel Movement

The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain. (NCT01044212)
Timeframe: Within 1 week of surgery

InterventionVAS pain score (Mean)
Bowel Medications3.6
Docusate Controls3.7

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Daily Presence of Delirium Using the Intensive Care Delirium Screening Checklist (ICDSC)

Measures as days without delirium with daily presence of delirium assessed using the Intensive Care Delirium Screening Checklist (ICDSC) (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

Interventiondays without delirium (Median)
Naloxegol Oral Tablet5
Placebo Oral Tablet6

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Days Without Mechanical Ventilation Support for Duration of ICU Stay

Measure is days without mechanical ventilation for duration of ICU stay as expressed as median and inter-Quartile Range (NCT02977286)
Timeframe: From ICU admission to ICU discharge or a maximum of 10 ICU days

Interventiondays (Median)
Naloxegol Oral Tablet0.5
Placebo Oral Tablet1

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ICU Days Without a SBM

Measured ICU days that subjects did not have a SBM (NCT02977286)
Timeframe: During period of ICU admission or a maximum of 10 ICU days

InterventionDays (Mean)
Naloxegol Oral Tablet2
Placebo Oral Tablet2

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Number of Patients That Required Use of the Study Laxative Protocol

A 4-step laxative protocol was initiated when there was no spontaneous bowel movement greater than or equal to 3 days time. Data collected on study laxative protocol included any use as well as the highest level needed. (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

Interventionparticipants (Number)
Naloxegol Oral Tablet5
Placebo Oral Tablet4

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Number of Patients With Loose and Unformed or Liquid SBM

Consistency of SBM is characterized in one of 4 categories: hard and formed, soft but formed, loose and unformed, and liquid. The number listed in the results section is the number of patients who had either loose or liquid SBM (as opposed to hard or soft formed). (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

InterventionParticipants (Count of Participants)
Naloxegol Oral Tablet5
Placebo Oral Tablet6

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Occurrence of Lower GI Tract Paralysis (≥3 Days Without a SBM)

Measurement is the number of subjects in each group having this occurrence of lower GI tract paralysis during time frame (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

InterventionParticipants (Count of Participants)
Naloxegol Oral Tablet2
Placebo Oral Tablet3

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Occurrence of Lower GI Tract Paralysis Requiring GI/Surgical Consultation

Number of patients with GI tract paralysis requiring Gastroenterology service or Surgical service consultation (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

InterventionParticipants (Count of Participants)
Naloxegol Oral Tablet0
Placebo Oral Tablet0

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Percentage of Daily Goal Reached for Enteral Nutrition Administration

Enteral nutrition is assessed as daily volume in mL and the reported measure is the percentage of daily goal of enteral nutrition met. (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

Interventionpercentage of daily goals met (Mean)
Naloxegol Oral Tablet54
Placebo Oral Tablet51

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Time to First Episode of Diarrhea

The number of patients in each group with > or equal to 1 episode of diarrhea after initiation of study drug. The time to first episode of diarrhea was measured in hours. (NCT02977286)
Timeframe: Study drug initiation to first episode of diarrhea in hours.

Interventionhours (Median)
Naloxegol Oral Tablet40
Placebo Oral Tablet109

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Time to First Spontaneous Bowel Movement (SBM)

Time to first spontaneous bowel movement during the ICU admission after opioid initiation (NCT02977286)
Timeframe: First occurrence after initiation of IV opioid therapy during period of ICU admission or a maximum of 10 ICU days

Interventionhours (Mean)
Naloxegol Oral Tablet52
Placebo Oral Tablet49

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Time to First Spontaneous Bowel Movement (SBM) Administration

Time to first spontaneous bowel movement during ICU admission after randomization (NCT02977286)
Timeframe: First occurrence after study randomization during period of ICU admission or a maximum of 10 ICU days

Interventionhours (Mean)
Naloxegol Oral Tablet41
Placebo Oral Tablet33

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Abdominal Pressure Measurement

On days when the patient had a urinary catheter in place for clinical reasons, a bladder pressure transducer was inserted and abdominal pressure was measured. The average daily maximum pressure score for each group is reported. (NCT02977286)
Timeframe: From randomization to ICU discharge (or removal of foley catheter) or a maximum of 10 ICU days

InterventionmmHg (Mean)
Naloxegol Oral Tablet10
Placebo Oral Tablet13

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Average Daily Opioid Requirement [in IV Fentanyl Equivalents (mcg Per Day)]

Average daily opioid requirement is converted to IV fentanyl equivalent listed in mcg per day (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

Interventionmcg per day (Mean)
Naloxegol Oral Tablet1420
Placebo Oral Tablet1600

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Daily Difference in the Pre-dose and Post-dose Clinical Opioid Withdrawal Scale (COWS) Score

Patients were evaluated 1 hour before and 2 hours after the administration of each dose of study medication using the Clinical Opioid Withdrawal Scale (COWS). COWS is used to help determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. The COWS score ranges from 0-36+. A score of 0 is no active opioid withdrawal. A score of 5-12 is mild; 13-24 is moderate; 25-36 is moderately severe and more than 36 is severe opioid withdrawal. (NCT02977286)
Timeframe: One hour before the daily study drug administration and 2 hours after the daily study drug administration

InterventionDifference of COWS score (Mean)
Naloxegol Oral Tablet-0.1
Placebo Oral Tablet0.2

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Daily Fluid Balance

Daily fluid balance measured in mL is the 24 hours ins and outs (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

InterventionmL (Mean)
Naloxegol Oral Tablet-338
Placebo Oral Tablet-210

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Daily Maximal Pain Scale Score

"Based on the highest daily Visual Analogue Scale-10 or Clinical Pain Observation tool assessment.~VAS-10 is Visual Analogue Scale which uses a nurse-administered 10 point rating scale. A measurement of 0-1 is minimal pain. A measurement of 10 is severe pain." (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

Interventionscore on a scale (Mean)
Naloxegol Oral Tablet0
Placebo Oral Tablet0

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Daily Maximal Sedation Assessment Scale (SAS) Score

"The Sedation Assessment Scale is rated 1 to 7. Score of 7 is dangerous agitation. Score of 1 is unarousable. Score of 2 is very sedated. The presence of coma is based on the every 4 hour sedation agitation score scale (SAS) assessment. A score of 1 or 2 any time during the day represents that a coma is present. A score of 3-7 represents a subject with no coma present.~Results listed here is days without coma (SAS score of 3-7)" (NCT02977286)
Timeframe: From randomization to ICU discharge or a maximum of 10 ICU days

Interventiondays (Median)
Naloxegol Oral Tablet3
Placebo Oral Tablet7

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Bowel Movement in the Study Period

The number of participants who had a bowel movement in the post operative study follow up (NCT03523715)
Timeframe: 5 days

InterventionParticipants (Count of Participants)
Prunes26
Control17

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Pain With Bowel Movement Measured

Likert scale from 0 to 10 in which higher values indicate more pain (NCT03523715)
Timeframe: 3 days

InterventionLikert scale 0-100 (Median)
Prunes60
Control40

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Requirements for Laxatives

The number of participants who used any laxatives (besides the prunes and stool softeners) during the study period. (NCT03523715)
Timeframe: 3 days

InterventionParticipants (Count of Participants)
Prunes7
Control6

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Satisfaction With Bowel Regimen

Likert scale from 0 to 10 in which higher values indicate more satisfaction (NCT03523715)
Timeframe: 3 day

InterventionLikert scale 0-100 (Median)
Prunes100
Control80

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Satisfaction With Surgery Overall

Likert scale from 0 to 10 in which higher levels indicate more satisfaction (NCT03523715)
Timeframe: 3 days

InterventionLikert scale 0-100 (Median)
Prunes100
Control100

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Stool Consistency of the First Bowel Movement

Bristol Stool chart in which stool consistency is described as type 1 to 7 with higher values indicating more liquid stool (NCT03523715)
Timeframe: 3 days

InterventionBristol Stool Scale (Median)
Prunes3
Control4

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Time to First Bowel Movement

Time to first bowel movement after surgery (NCT03523715)
Timeframe: 3 days

Interventionhours post surgery (Mean)
Prunes57.6
Control53.8

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Laxative Use Within 3 Days of Surgery

Participant response to question: Did you take any laxatives to help you have a bowel movement in those first three days after your surgery?(yes/no) Rate of laxative use in the postoperative period was calculated for sensitivity analyses and possible adjustment of statistical models based on any group differences. (NCT04380090)
Timeframe: 3 days postoperative

InterventionParticipants (Count of Participants)
Drug: Docusate Sodium16
Drug: Propylene Glycol19

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Opioid Use Within 3 Days of Surgery

Participant response to question: In the first three days following your surgery, did you take any of the opioid pain medicine prescribed by your surgeon?(yes/no) Rate of opioid use in the postoperative period was calculated for sensitivity analyses and possible adjustment of statistical models based on any group differences. (NCT04380090)
Timeframe: 3 days postoperative

InterventionParticipants (Count of Participants)
Drug: Docusate Sodium58
Drug: Propylene Glycol57

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Straining With BM

For patients who had a BM within 3 days: rated 0 no straining to 10 worst straining imaginable; 3 categories developed: 0 = score of 0; 1 = score of 1-5 and 2 = score of 6-10 (NCT04380090)
Timeframe: 3 days postoperative

,
Interventionparticipants (Number)
score = 0score = 1score = 2
Drug: Docusate Sodium6185
Drug: Propylene Glycol7214

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Bowel Movement (BM) Within 3 Days of Surgery

Number of people who report normal bowel movement in the first three postoperative days following single total knee joint replacement (NCT04380090)
Timeframe: 3 days postoperative

InterventionParticipants (Count of Participants)
Drug: Docusate Sodium29
Drug: Propylene Glycol32

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Day 3 Composite 3 Symptom Score

The 3 symptom composite score was generated from 3 symptoms: Cough, Headache, and Fatigue. Each symptom was scored as such: 0 was not affected, 1 was little affected, 2 moderately affected, 3 severely affected. A composite score was generated using the score given for each individual symptom, ie. the sum of symptomatic score of Cough + symptomatic score of Headache + symptomatic score of Fatigue. The maximum and most symptomatic composite score could be 9 each day. The minimum score could be 0 . This score was calculated calculated for BL/day1, day 2 and day 3 . This outcome is the composite 3 symptom score on day 3. (NCT04811339)
Timeframe: This is the day 3 composite score

Interventionscore on a scale (Mean)
Open Label BSS Therapy -Completed1.4

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Measure of Daily Stool Frequency for Patients With COVID Treated With Bismuth

Number of bowel movements recorded over the 3 day study. Baseline (BL) /day1 + Day 2 + Day 3 (NCT04811339)
Timeframe: 3 days

Interventionbowel movements (Mean)
Open Label BSS Completed Patients3

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Day 3 Composite 5 Symptom Score

The 5 symptom composite score was generated from 5 symptoms: Cough, Headache, Fatigue, Shortness of Breath, and Anosmia (no smell). Each symptom was scored as such: 0 was not affected, 1 was little affected, 2 moderately affected, 3 severely affected. A composite score was generated using the score given for each individual symptom, ie. the sum of symptomatic score of Cough + symptomatic score of Headache + symptomatic score of Fatigue + symptomatic score of Shortness of Breath + symptomatic score of anosmia. The maximum and most symptomatic composite score could be 15 each day. The minimum score could be 0. This score was calculated calculated for BL/day1, day 2 and day 3 . This outcome is the composite 5 symptom score on day 3. (NCT04811339)
Timeframe: The score was taken at BL (baseline)/day 1, Day 2 ( 24 hours after BSS started ) and Day 3 (48 hours after BSS started). This Outcome is Day 3 score.

Interventionscore on a scale (Mean)
Open Label BSS Therapy -Completed2.9

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