Page last updated: 2024-11-12

bismuth tripotassium dicitrate

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Description

bismuth tripotassium dicitrate: contains tripotassium di-citratobismuthate used in gastric & duodenal ulcer therapy; do not confuse with colloidal bismuth subnitrate [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID10101269
MeSH IDM0043532

Synonyms (31)

Synonym
D07587
de-nol (tn)
57644-54-9
de-noltab
gastrodenol
1,2,3-propanetricarboxylic acid, 2-hydroxy-, bismuth(3+) potassium salt (2:1:3)
tripotassium dicitratobismuthate
einecs 260-872-5
bismuth(3+) tripotassium bis(2-hydroxypropane-1,2,3-tricarboxylate)
bismuth subcitrate
bismuth tripotassium dicitrate
bismuth subcitrate potassium
colloidal bismuth subcitrate
AKOS005110988
unii-hs813p8qpx
hs813p8qpx ,
FT-0623129
colloidal bismuth subcitrate [mi]
tripotassium dicitratobismuthate [who-dd]
bismuth subcitrate [vandf]
bismuth subcitrate, colloidal
bismuth subcitrate [who-dd]
CS-3966
HY-B0796
B4377
bismuth(iii) tripotassium 2-hydroxypropane-1,2,3-tricarboxylate
tripotassium;2-hydroxypropane-1,2,3-tricarboxylate;5-hydroxy-2,8,9-trioxa-1-bismabicyclo[3.3.2]decane-3,7,10-trione
tripotassium dicitrate bismuthate
bismuth tripotassium dicitrate; bismuth subcitrate; duosol; gastrodenol; bismuth subcitrate potassium; de-nol
BCP10508
bismuth;tripotassium;2-hydroxypropane-1,2,3-tricarboxylate

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" During 12 months of follow-up, no side-effects were reported by TDB-treated patients, blood bismuth levels did not rise above discontinuation threshold concentrations (greater than 50 micrograms/L in the first 6 months, or greater than 100 micrograms/L in the second 6 months), and there were no adverse effects on haematological or biochemical indices."( The safety and efficacy of tripotassium dicitrato bismuthate (De-Nol) maintenance therapy in patients with duodenal ulceration.
Dunk, AA; Mowat, NA; O'Morain, C; Prabhu, U; Tobin, A, 1990
)
0.28
"To evaluate two triple-therapy (TT) regimens of colloidal bismuth subcitrate (CBS), metronidazole, and tetracycline HCl in eradicating Helicobacter pylori, with particular attention to the frequency of resulting adverse effects of the two therapies."( Use of high efficacy, lower dose triple therapy to reduce side effects of eradicating Helicobacter pylori.
Andrews, P; Borody, TJ; Brandl, S; Ferch, N; Hyland, L; Jankiewicz, E, 1994
)
0.29
" pylori is equally efficacious to the standard 4 x/day therapy, but is accompanied by fewer and milder adverse effects."( Use of high efficacy, lower dose triple therapy to reduce side effects of eradicating Helicobacter pylori.
Andrews, P; Borody, TJ; Brandl, S; Ferch, N; Hyland, L; Jankiewicz, E, 1994
)
0.29
"Bismuth subcitrate is a known nephrotoxic agent that may lead to acute oliguric renal failure when ingested in toxic doses."( Bismuth subcitrate nephrotoxicity. A reversible cause of acute oliguric renal failure.
Ari, F; Ates, F; Sarikaya, M; Sevinc, A; Ulu, R, 2002
)
0.31
" However, toxic effects resulting from therapeutic bismuth compounds are still documented in animals and humans."( The protective roles of some lichen species on colloidal bismuth subcitrate genotoxicity.
Aslan, A; Geyikoglu, F; Turkez, H, 2007
)
0.34
" Adverse events occurred in 55 patients (15."( Effectiveness and Safety of Pylera® in Patients Infected by Helicobacter Pylori: A Multicenter, Retrospective, Real Life Study.
Allegretta, L; Baldassarre, G; Brandimarte, G; Cassieri, C; De Bastiani, R; Di Mario, F; Elisei, W; Ferronato, A; Franceschi, M; Licci, C; Miraglia, C; Penna, A; Picchio, M; Pranzo, G; Rizzo, GL; Savarino, E; Scida, S; Tursi, A, 2018
)
0.48
" The aim of this study was to evaluate the compliance, adverse effects and effectiveness of this treatment with the new galenic three-in-one capsule formulation containing bismuth subcitrate, metronidazole and tetracycline (Pylera®)."( Compliance, adverse effects and effectiveness of first line bismuth-containing quadruple treatment (Pylera®) to eradicate Helicobacter pylori infection in 200 patients.
Castro Fernández, M; Grande Santamaría, L; Keco Huerga, A; Lamas Rojas, E; Llorca Fernández, R; Pabón Jaén, M; Rojas Feria, M; Romero García, T, 2019
)
0.51
" The compliance and adverse effects of the treatment were evaluated via telephone contact and via an interview during the clinical revision."( Compliance, adverse effects and effectiveness of first line bismuth-containing quadruple treatment (Pylera®) to eradicate Helicobacter pylori infection in 200 patients.
Castro Fernández, M; Grande Santamaría, L; Keco Huerga, A; Lamas Rojas, E; Llorca Fernández, R; Pabón Jaén, M; Rojas Feria, M; Romero García, T, 2019
)
0.51
"5% (57/200) of the patients experienced adverse effects, which led to abandoning the treatment in only seven subjects."( Compliance, adverse effects and effectiveness of first line bismuth-containing quadruple treatment (Pylera®) to eradicate Helicobacter pylori infection in 200 patients.
Castro Fernández, M; Grande Santamaría, L; Keco Huerga, A; Lamas Rojas, E; Llorca Fernández, R; Pabón Jaén, M; Rojas Feria, M; Romero García, T, 2019
)
0.51
" Adverse drug effects were found in 36 patients from the twice a day group and 50 patients from the four times a day group (P = ."( Efficacy and safety of twice a day, bismuth-containing quadruple therapy using high-dose tetracycline and metronidazole for second-line Helicobacter pylori eradication.
Kim, JH; Kim, JY; Lee, SY; Park, HS; Sung, IK, 2020
)
0.56
"5 g/d of metronidazole, and 600 mg/d of bismuth subcitrate for one week is effective and safe as the conventional four times a day therapy."( Efficacy and safety of twice a day, bismuth-containing quadruple therapy using high-dose tetracycline and metronidazole for second-line Helicobacter pylori eradication.
Kim, JH; Kim, JY; Lee, SY; Park, HS; Sung, IK, 2020
)
0.56

Pharmacokinetics

ExcerptReferenceRelevance
" However, the intermediate half-life of 5-11 days represents most of the clearance and elimination."( Safety and pharmacokinetics: colloidal bismuth subcitrate.
Benet, LZ, 1991
)
0.28
" After the last dose the geometric mean for Cmax for 500 mg bid of GR122311X was 5 ng."( Comparative pharmacokinetics of bismuth from ranitidine bismuth citrate (GR122311X), a novel anti-ulcerant and tripotassium dicitrato bismuthate (TDB).
Frazer, NM; Keene, ON; Lacey, LF; Smith, JT, 1994
)
0.29

Compound-Compound Interactions

ExcerptReferenceRelevance
"In this random study, the efficacy of either colloidal bismuth subcitrate (CBS) or metronidazole in combination with an H2-antagonist in the treatment of various gastric pathologies was evaluated, along with the trends in antibody levels."( Comparison of colloidal bismuth subcitrate and metronidazole, both in combination with an H2-antagonist as therapy for Helicobacter pylori.
Albano, A; Baffone, W; Barbieri, E; Belbusti, F; Bruscolini, F; Fabi, MT; Pianetti, A; Salvaggio, L, 1997
)
0.3
" pylori than ranitidine when given with amoxicillin plus metronidazole for the treatment of duodenal ulcer, as both early reinfection and ulcer recurrence are diminished."( Ranitidine versus colloidal bismuth subcitrate in combination with amoxicillin and metronidazole for eradicating Helicobacter pylori in patients with duodenal ulcer.
Blanco, M; Carpintero, P; Pajares, JM, 1997
)
0.3
"To study the efficacy and side effects of furazolidone when given for 1 week in combination with bismuth subcitrate, amoxicillin, and omeprazole."( Short-duration furazolidone therapy in combination with amoxicillin, bismuth subcitrate, and omeprazole for eradication of Helicobacter pylori.
Hasan, SR; Reza, PM; Roham, SR; Vahid, V,
)
0.13
"One week of furazolidone in combination with 2 weeks of amoxicillin, omeprazole, and bismuth subcitrate is a safe and cost-effective regimen for the eradication of H pylori."( Short-duration furazolidone therapy in combination with amoxicillin, bismuth subcitrate, and omeprazole for eradication of Helicobacter pylori.
Hasan, SR; Reza, PM; Roham, SR; Vahid, V,
)
0.13
" This study aimed to compare the efficacy of Biling Weitong granules (BLWTG) combined with quadruple therapy in patients with refractory HP infection who had previously failed eradication therapy."( Clinical Effects of Biling Weitong Granules in Combination with Quadruple Therapy on Refractory Helicobacter pylori Infection.
Chen, DL; Chen, YL; Li, ZS; Zhang, HQ, 2023
)
0.91
" And those treated with BLWTG (5 g three times daily) combined with the EACB group for 14 days (BLWTG+EACB group)."( Clinical Effects of Biling Weitong Granules in Combination with Quadruple Therapy on Refractory Helicobacter pylori Infection.
Chen, DL; Chen, YL; Li, ZS; Zhang, HQ, 2023
)
0.91

Bioavailability

ExcerptReferenceRelevance
" Hence, the use of effective but poorly absorbed bismuth preparations should be encouraged for bismuth-based eradication therapies."( Double-blind comparison of absorbable colloidal bismuth subcitrate and nonabsorbable bismuth subnitrate in the eradication of Helicobacter pylori and the relief of nonulcer dyspepsia.
Delves, HT; Phillips, RH; Powell, JJ; Seed, PT; Sieniawska, CE; Thompson, RP; Whitehead, MW, 2000
)
0.31
"The objective of this study was to determine the impact of omeprazole on bismuth (Bi) bioavailability when given in a three-in-one capsule containing bismuth biskalcitrate, metronidazole, and tetracycline."( Influence of omeprazole on bioavailability of bismuth following administration of a triple capsule of bismuth biskalcitrate, metronidazole, and tetracycline.
Aumais, C; Lefebvre, M; Massicotte, J; Spénard, J; Tremblay, C, 2004
)
0.32

Dosage Studied

ExcerptRelevanceReference
" Substitution of doxycycline for tetracycline HCl offers advantages of less frequent dosing and extrarenal excretion."( Helicobacter pylori eradication with doxycycline-metronidazole-bismuth subcitrate triple therapy.
Andrews, P; Borody, TJ; Brandl, S; Devine, M; George, LL; Lenne, J; Moore-Jones, D; Walton, M, 1992
)
0.28
"Electron microscopic examination of upper gastrointestinal biopsies with x-ray microanalysis was used to detect electron-dense particles of bismuth in the mucosa of the upper gastrointestinal tract, 30-60 minutes after oral dosing with either tripotassium dicitrato bismuthate [De-Noltab; Brocades (Great Britain) Ltd."( Transmucosal penetration of bismuth particles in the human stomach.
Hudson, M; Lewin, JF; Nwokolo, CU; Pounder, RE, 1992
)
0.28
" It appears prudent to halve tripotassium dicitrato bismuthate dosage in patients with severe renal insufficiency (creatinine clearance less than or equal to 20 ml/min) to avoid any possible toxic risks."( Tripotassium dicitrato bismuthate: absorption and urinary excretion of bismuth in patients with normal and impaired renal function.
Gladziwa, U; Ittel, TH; Klotz, U; Schweinsberg, F; Treiber, G; Walker, S, 1991
)
0.28
" The results indicate that (i) colloidal bismuth subcitrate-induced stimulation of endogenous prostacyclin content ("adaptive cytoprotection") of rat gastroduodenal mucosa may contribute to its therapeutic effect; (ii) the effect of colloidal bismuth subcitrate is not due exclusively to the bismuth content of the molecule, but seems to be connected with the structure of colloidal bismuth subcitrate itself; (iii) the effect seems to be dose-dependent, showing a dose-response relationship."( Colloidal bismuth subcitrate evokes adaptive cytoprotection in rat gastric mucosa.
Balint, GA, 1991
)
0.28
"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 second group also of 10 patients was treated with CBS 120 mg qid and after 2 days they received aspirin and CBS simultaneously in the dosage mentioned above for another 4 days."( [Protective effect of colloidal bismuth subcitrate on gastric mucosal lesion induced by aspirin].
Chen, J; Chen, SP; Wen, SH, 1990
)
0.28
" Before dosing with D-penicillamine, the median 24 h urinary bismuth output was 55 micrograms 24 h-1 (range 17-156 micrograms 24 h-1) and following dosing with D-penicillamine the median 24 h urinary bismuth output was 53 micrograms 24 h-1 (range 12-156 micrograms 24 h-1)."( D-penicillamine does not increase urinary bismuth excretion in patients treated with tripotassium dicitrato bismuthate.
Nwokolo, CU; Pounder, RE, 1990
)
0.28
"Two studies measured plasma concentrations of bismuth during dosing with tripotassium dicitrato bismuthate (De-Noltab)."( The absorption of bismuth from oral doses of tripotassium dicitrato bismuthate.
Gavey, CJ; Nwokolo, CU; Pounder, RE; Smith, JT, 1989
)
0.28
"The pharmacokinetics of bismuth subcitrate were studied in plasma and urine under conditions of single and multiple dosing (28-56 days) using atomic absorption technique."( Absorption and elimination of bismuth from oral doses of tripotassium dicitrato bismuthate.
Froomes, PR; Keech, AC; McLean, AJ; McNeil, JJ; Wan, AT, 1989
)
0.28
" However, no such intoxication has been reported with CBS used at its recommended dosage in the acute treatment of peptic ulcer disease, and no other serious adverse effects have been associated with CBS."( Colloidal bismuth subcitrate. A review of its pharmacodynamic and pharmacokinetic properties, and its therapeutic use in peptic ulcer disease.
Benfield, P; Monk, JP; Wagstaff, AJ, 1988
)
0.27
" Because it has been suggested that the lower relapse rate for duodenal ulcer following colloidal bismuth subcitrate (CBS) is due to suppression of C pylori we investigated different formulations and dosing of CBS for their efficacy in clearing C pylori."( Treatment of Campylobacter pylori gastritis: a pilot study using pirenzepine dihydrochloride (Gastrozepin) and three formulations of colloidal bismuth subcitrate (De-Nol).
Ali, MR; Brown, P; Lane, M; Morris, A; Palmer, R, 1988
)
0.27
"Forty patients with endoscopically proven duodenal ulceration have cooperated in a clinical trial to compare the ulcer healing effect of colloidal bismuth subcitrate (CBS) at standard dosage administered either twice or four times a day."( Colloidal bismuth subcitrate as coated tablets: four times versus twice daily dosage in duodenal ulcer.
Bianchi Porro, G; Lazzaroni, M; Parente, F; Prada, A, 1986
)
0.27
"Fifty three patients with endoscopically proven duodenal ulceration have cooperated in a clinical trial to compare the ulcer healing effect of tripotassium dicitrato bismuthate (TDB) at standard dosage administered either twice or four times daily."( Twice daily tripotassium dicitrato bismuthate in the treatment of duodenal ulceration.
Hollanders, D, 1986
)
0.27
" Twenty four men with duodenal ulcers were studied before and on the 8th day of dosing with either ranitidine bismuth citrate 800 mg twice daily or ranitidine 300 mg twice daily (double blind, randomised, parallel groups)."( Effect of ranitidine bismuth citrate on postprandial plasma gastrin and pepsinogens.
Fraser, AG; Hudson, M; Lam, WM; Luk, YW; Pounder, RE; Samloff, IM; Sawyerr, AM; Sercombe, J, 1993
)
0.29
"One hundred and thirty patients with proven H pylori infection (by at least two tests) were treated with low dose triple therapy (DeNol 1 qid, tetracycline 250 mg qid and metronidazole 200 mg qid for 2 weeks; dosing with meals and at night); 83 were given a standard prescription for triple therapy (dispensed in bottles) and 47 were given a medication pack with times of dosing clearly marked."( An audit of low dose triple therapy for eradication of Helicobacter pylori.
Ali, MR; Chua, LE; Fraser, AG; Hollis, B; Little, SV; Moore, L, 1996
)
0.29
" After dosing with bismuth alone or in association with ranitidine hydrochloride, bismuth was detected in several organs and deposition was not influenced by gastric pH."( Distribution of bismuth in the rat after oral dosing with ranitidine bismuth citrate and bismuth subcitrate.
Canena, J; Leitão, J; Pinheiro, T; Pinto, AS; Quina, MG; Reis, J; Santos, AM, 1998
)
0.3
" Subsequent studies should be performed to evaluate antibiotic resistance, doses, dosing intervals, duration of treatment, and safety of these two regimes."( Failure of Helicobacter pylori treatment after regimes containing clarithromycin: new practical therapeutic options.
Coelho, L; Moretzsohn, L; Sanches, B; Vieira, G, 2008
)
0.35
"We aimed to evaluate the effectiveness and safety of bismuth-containing quadruple therapy plus postural change after dosing for Helicobacter pylori eradication in gastrectomized patients."( Efficacy of a quadruple therapy regimen for Helicobacter pylori eradication after partial gastrectomy.
Bao, ZJ; Huang, YQ; Shi, DM; Xiang, P; Xiao, L; Yin, SM; Zhang, F; Zhang, GS, 2016
)
0.43
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (771)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990199 (25.81)18.7374
1990's330 (42.80)18.2507
2000's151 (19.58)29.6817
2010's79 (10.25)24.3611
2020's12 (1.56)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 33.65

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 moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index33.65 (24.57)
Research Supply Index7.05 (2.92)
Research Growth Index4.45 (4.65)
Search Engine Demand Index49.01 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (33.65)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials334 (40.58%)5.53%
Reviews72 (8.75%)6.00%
Case Studies33 (4.01%)4.05%
Observational2 (0.24%)0.25%
Other382 (46.42%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (23)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Helicobacter Pylori Eradication Using a Bismuth Quadruple Therapy Among Asymptomatically Infected Adults in El Paso, Texas: A Pilot Study. [NCT01335334]Phase 450 participants (Anticipated)Interventional2011-03-31Recruiting
Twice-a-day PPI, Tetracycline, Metronidazolequadruple Therapy With Pylera® or Lactobacillus Reuteri for Treatment naïve or for Retreatment of H. Pylori: Two Randomized Pilot Studies [NCT03925818]99 participants (Actual)Interventional2017-08-29Terminated(stopped due to Lactobacillus reuteri (Gastrus®) was not anymore available in the region)
Visiting Staff, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan [NCT04853875]Phase 4104 participants (Actual)Interventional2021-04-19Completed
Bismuth Quadruple Therapy Versus Standard Triple Therapy for the First-line Treatment of Helicobacter Pylori Infection in Children: Efficacy and Safety [NCT06143124]Phase 4216 participants (Anticipated)Interventional2022-03-03Recruiting
Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given X 10 Days With Omeprazole in Eradication of Helicobacter Pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given X 7 Days [NCT00669955]Phase 3440 participants (Actual)Interventional2008-06-30Completed
Comparing the Efficacy and Impact on Gastrointestinal Microbiome of Reverse Hybrid Therapy and Bismuth Quadruple Therapy in Helicobacter Pylori Eradication [NCT02547038]352 participants (Actual)Interventional2015-02-28Completed
A Comparison of High-dose Dual Therapy and Half-dose Clarithromycin-containing Bismuth Quadruple Therapy for H.P Eradication in Elderly Patients [NCT04101708]Phase 4100 participants (Anticipated)Interventional2019-09-20Not yet recruiting
Comparison Between Tailored Therapy Guided by a Non-invasive Antibiotic Susceptibility Test and Empiric Treatment for First-line Helicobacter Pylori Eradication in Patients With Dyspepsia: a Randomized Controlled Trial. [NCT04107194]Phase 3362 participants (Anticipated)Interventional2020-01-14Recruiting
Proton Pump Inhibitors and the Risk of Hospitalization for Community-acquired Pneumonia: Replicated Cohort Studies With Meta-analysis [NCT02555852]4,238,504 participants (Actual)Observational2011-09-30Completed
The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Subjects With Non-alcoholic Fatty Liver Disease [NCT01876108]Phase 2100 participants (Anticipated)Interventional2012-07-31Completed
Phytomedicine-based and Quadruple Therapies in Helicobacter Pylori Infection. A Comparative Randomized Trial [NCT02004197]Phase 2/Phase 3176 participants (Actual)Interventional2010-01-31Completed
Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy as Rescue Treatment for Helicobacter Pylori Infection After Failure of Several Therapy [NCT02894268]Phase 4300 participants (Anticipated)Interventional2016-02-29Recruiting
Phase IV, Multicenter, Open Label, Randomized Study in Parallel Groups To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol®) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Patients With NSAID Induced [NCT02788123]Phase 49 participants (Actual)Interventional2017-03-03Terminated(stopped due to Internal reassessment of the medicinal product development strategy by Sponsor)
Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy [NCT00520949]176 participants (Actual)Interventional2006-10-31Completed
Prospective Randomised Trial of First and Second Line Treatments of Helicobacter Pylori Infection in Slovenia [NCT04359966]560 participants (Anticipated)Interventional2020-05-10Not yet recruiting
Comparison of Hybrid and Bismuth Containing Quadruple Therapies for Helicobacter Pylori Eradication: a Randomized Controlled Trial [NCT02541864]330 participants (Actual)Interventional2013-07-31Completed
Comparing 10-day Reverse Hybrid Therapy and 10-day Triple Therapy Plus Bismuth Therapy on Helicobacter Pylori Eradication [NCT04566211]440 participants (Anticipated)Interventional2020-01-01Recruiting
Ten Days Quadruple Versus Sequential Therapy as Empirical First and Second Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial [NCT01760824]391 participants (Actual)Interventional2011-05-31Completed
A Phase II Clinical Trial of Anti-Helicobacter Pylori Treatment in Endoscopically Diagnosed Low-Grade Localized Gastric Lymphoma [NCT00003151]Phase 296 participants (Anticipated)Interventional1997-09-30Completed
Personalized Treatment for Refractory H Pylori Infection [NCT02547025]126 participants (Actual)Interventional2012-08-01Completed
Compare 14-day Reverse Hybrid Therapy and 14-day Triple Therapy Plus Bismuth on Helicobacter Pylori Eradication [NCT03321773]440 participants (Anticipated)Interventional2017-01-31Recruiting
Adding Bismuth to Rabeprazole-based First-line Triple Therapy Does Not Improve the Eradication of Helicobacter Pylori [NCT03108287]Phase 4162 participants (Actual)Interventional2013-04-01Completed
The Studies of Integrating Gastric and Gut Microbiota, F. Prausnitzii Metabolites, Microenvironment, and Epigenetics to Identify the Cancer Risk of H. Pylori-related Precancerous Conditions Through an AI System and Control the Risky by Probiotic Supplemen [NCT04527055]Phase 4312 participants (Anticipated)Interventional2020-05-06Enrolling by invitation
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00669955 (7) [back to overview]Clarithromycin Resistance
NCT00669955 (7) [back to overview]H. Pylori Eradication and Presence or Past History of Peptic Ulcers
NCT00669955 (7) [back to overview]Helicobacter Pylori Eradication Confirmed by Urea Breath Test
NCT00669955 (7) [back to overview]Metronidazole Resistance
NCT00669955 (7) [back to overview]Number of Patients Experiencing Treatment Emergent Adverse Events.
NCT00669955 (7) [back to overview]Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level
NCT00669955 (7) [back to overview]Overall Compliance to Study Medications
NCT02541864 (1) [back to overview]Number of Participants in Which H. Pylori Was Eradicated
NCT02547038 (1) [back to overview]Number of Participants in Which H. Pylori Was Eradicated

Clarithromycin Resistance

Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to clarithromycin at baseline. Resistance to clarithromycin defined as Minimum Inhibitory Concentration (MIC) of 1 ug/ml and above (NCT00669955)
Timeframe: Measured at baseline

Interventionparticipants (Number)
Quadruple Therapy (OBMT) 10 Days30
Triple Therapy (OAC) 7 Days2

[back to top]

H. Pylori Eradication and Presence or Past History of Peptic Ulcers

Eradication rates in the subset of patients with peptic ulcer (current or past history) at baseline are reported based on the per protocol population. Eradication must be confirmed at week 6 and week 10 by a negative Urea Breath Test conducted within the allocated windows. (NCT00669955)
Timeframe: Week 6 and week 10 follow-up visits

InterventionParticipants (Number)
Quadruple Therapy (OBMT) 10 Days18
Triple Therapy (OAC) 7 Days15

[back to top]

Helicobacter Pylori Eradication Confirmed by Urea Breath Test

H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits. (NCT00669955)
Timeframe: Week 6 and week 10 follow-up visits

InterventionParticipants (Number)
Quadruple Therapy (OBMT) 10 Days166
Triple Therapy (OAC) 7 Days112

[back to top]

Metronidazole Resistance

Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to metronidazole at baseline. Resistance to metronidazole defined as Minimum Inhibitory Concentration (MIC) above 8 ug/ml (NCT00669955)
Timeframe: Measured at baseline

Interventionparticipants (Number)
Quadruple Therapy (OBMT) 10 Days38
Triple Therapy (OAC) 7 Days28

[back to top]

Number of Patients Experiencing Treatment Emergent Adverse Events.

"A treatment-emergent adverse event is defined as an event not present prior to exposure to the study medication or any event already present that worsens in either intensity or frequency following exposure to study medication up to 30 days after study discontinuation.~All safety analysis based on the safety population." (NCT00669955)
Timeframe: at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.

InterventionParticipants (Number)
Quadruple Therapy (OBMT) 10 Days101
Triple Therapy (OAC) 7 Days112

[back to top]

Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level

Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter) (NCT00669955)
Timeframe: Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only

Interventionparticipants (Number)
Quadruple Therapy (OBMT) 10 Days0

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Overall Compliance to Study Medications

Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population (NCT00669955)
Timeframe: At the end of the treatment phase (days 8-14)

Interventionparticipants (Mean)
Quadruple Therapy (OBMT) 10 Days97.58
Triple Therapy (OAC) 7 Days97.47

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Number of Participants in Which H. Pylori Was Eradicated

Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status. (NCT02541864)
Timeframe: at the 6th week after the end of anti- H. pylori therapy

Interventionparticipants (Number)
Pantoprazole+Bismuth+Tetra+Metro154
Hybrid Therapy154

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Number of Participants in Which H. Pylori Was Eradicated

Evaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori) (NCT02547038)
Timeframe: sixth week after the end of anti- H. pylori therapy

Interventionparticipants (Number)
Pantoprazole+Bismuth+Tetra+Metro169
(Panto+Amox+Clar+Metr)+(Panto+Amox)170

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