A double blind, randomized, placebo-control study to evaluate the effect of Bacillus coagulans supplementation in management of symptoms of IBS.

nique Biotech Limited0 个研究点目标入组 136 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Subjects of either sex having age group 18-60 years.(Both inclusive)
•2.Must include all of the following criteria, (Rome III Criteria)
•A. Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:
•a)Improvement with defecation
•b)Onset associated with a change in frequency of stool
•c)Onset associated with a change in the form (appearance) of stool
•B. No evidence of an inflammatory, anatomic, metabolic or neoplastic process that explains the subjectâ??s symptoms
•3.Weekly average of the worst daily (in the past 24 hours) abdominal pain score of >= 3.0 on a 11 point scale.
•4.An average of fewer than 3 CSBMs per week. CSBM is defined as a bowel movement, not resulting from use of laxatives that is associated with a sensation of completeness.
•5.Able to provide informed consent.

•1. Participants with a BSS (Bristol Stool Scale) score of 7 (watery, no solid pieces) or 6 (fluffy pieces with ragged edges, a mushy stool) for > 25 % of their BMs during the 12 weeks before screening or, during the run-in period. This does not include BMs that were induced by the use of laxatives.
•2. Patients presenting any disease that may affect bowel motility other than the clinical diagnosis of IBS.
•3. Presence of rectal bleeding, recent weight loss (greater than 5 kg in the past month) or iron deficiency anemia.
•4. History of lactose intolerance and other malabsorption syndromes (e.g. fructose malabsorption).
•5. Previous abdominal surgery and patients suffering from severe systemic disease.
•6. Use of probiotic or another investigational product within 3 months of the screening visit.
•7. Pregnant or breast-feeding or planning on becoming pregnant. Women of child-bearing potential not using effective contraception.
•8. Use of any antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of screening.
•9. Daily use of laxative within 1 month of screening.
•10. Current use, or use within the past 3 months, of narcotics or other medications for IBS symptom management (e.g. alosetron, tegaserod, lubiprostone, antispasmodics, antidiarrheals).

发起方

nique Biotech Limited