pulmicort and Intestinal-Diseases

Topics: Age Factors; Aged; Aged, 80 and over; Anti-Infective Agents; Anti-Inflammatory Agents; Antidiarrheals; Budesonide; Cholestyramine Resin; Chronic Disease; Clostridioides difficile; Colitis, Microscopic; Diagnosis, Differential; Diarrhea; Enterocolitis, Pseudomembranous; Glucocorticoids; Humans; Intestinal Diseases; Irritable Bowel Syndrome; Medical History Taking; Metronidazole; Randomized Controlled Trials as Topic; Time Factors

Severe acute malnutrition (SAM) in children in many countries still carries unacceptably high mortality, especially when complicated by secondary infection or metabolic derangements. New therapies are urgently needed and we have identified mucosal healing in the intestine as a potential target for novel treatment approaches.. The TAME trial (Therapeutic Approaches for Malnutrition Enteropathy) will evaluate four novel treatments in an efficient multi-arm single-blind phase II design. In three hospitals in Zambia and Zimbabwe, 225 children with SAM will be randomised to one of these treatments or to standard care, once their inpatient treatment has reached the point of transition from stabilisation to increased nutritional intake. The four interventions are budesonide, bovine colostrum or N-acetyl glucosamine given orally or via nasogastric tube, or teduglutide given by subcutaneous injection. The primary endpoint will be a composite score of faecal inflammatory markers, and a range of secondary endpoints include clinical and laboratory endpoints. Treatments will be given daily for 14 days, and evaluation of the major endpoints will be at 14 to 18 days, with a final clinical evaluation at 28 days. In a subset of children in Zambia, endoscopic biopsies will be used to evaluate the effect of interventions in detail.. The study has been approved by the University of Zambia Biomedical Research Ethics Committee (006-09-17, dated 9. NCT03716115; Pre-results.

Topics: Animals; Biomarkers; Budesonide; Cattle; Child; Clinical Trials, Phase II as Topic; Colostrum; Glucosamine; Humans; Intestinal Diseases; Multicenter Studies as Topic; Peptides; Randomized Controlled Trials as Topic; Severe Acute Malnutrition; Single-Blind Method; Treatment Outcome; Zambia; Zimbabwe

Therapy of acute intestinal GVHD is still one of the main challenges after allogeneic transplantation. Increasing systemic immunosuppression (IS) is the first choice and includes corticosteroids and lymphocyte antibodies, often associated with severe side-effects. In inflammatory bowel diseases such as Crohn's disease and ulcerative colitis, topical steroid therapy is used very successfully. Because of the similarity between these and acute intestinal GVHD we conducted a trial with oral budesonide (Budenofalk), a new topically active glucocorticoid, to treat patients with acute GVHD > or = grade II. After a diagnosis of aGVHD > or = grade II, 22 patients received increased IS, mainly systemic corticosteroids, and additionally budesonide 9 mg/day divided into three doses. Improvement in aGVHD, infectious side-effects, reduction of systemic IS and outcome were documented. Results were compared with the results of 19 control patients, who were treated only by increasing IS dose. In 17/22 patients (70%), treated with budesonide, the acute intestinal GVHD resolved and no relapse occurred after decreasing the systemic IS, while continuing budesonide. In only 8/19 patients in the control group did the acute intestinal GVHD resolve and 2/8 patients had a relapse of intestinal GVHD after decreasing IS, with an overall response of 33%. No severe intestinal infections occurred. We conclude that budesonide may be effective in acute intestinal GVHD as a topical corticosteroid and prospective, randomized studies should demonstrate its efficacy in allowing reduction of systemic immunosuppressive therapy, and its side-effects.

Topics: Acute Disease; Administration, Topical; Adolescent; Adrenal Cortex Hormones; Adult; Behavior Therapy; Bone Marrow Transplantation; Budesonide; Child; Endoscopy; Female; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Immunosuppression Therapy; Intestinal Diseases; Male; Middle Aged; Sibling Relations; Survival Rate; Time Factors; Transplantation, Homologous; Treatment Outcome

Topics: Acute Disease; Anti-Inflammatory Agents; Budesonide; Child, Preschool; Graft vs Host Disease; Humans; Intestinal Diseases; Male; Treatment Outcome