A study to evaluate, safety and efficacy of probiotic Unique IS2 in adults suffering from Irritable bowel syndrome in comparison with placebo.

Phase 2

Completed

Brief Summary: To investigate effect of UBLAC (Bacillus coagulans Unique IS2 - Probiotic) supplementation versus placebo on Irritable Bowel Syndrome subjects for the management of symptoms in subjects, in a double-blind, randomized controlled study.

Recruitment & Eligibility

Inclusion Criteria

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 â‰¥ 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.

Exclusion Criteria

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.
Patients presenting any disease that may affect bowel motility other than the clinical diagnosis of IBS.
Presence of rectal bleeding, recent weight loss (greater than 5 kg in the past month) or iron deficiency anemia.
History of lactose intolerance and other malabsorption syndromes (e.g. fructose malabsorption).
Previous abdominal surgery and patients suffering from severe systemic disease.
Pregnant or breast-feeding or planning on becoming pregnant.
Women of child-bearing potential not using effective contraception.
Use of any antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of screening.
Daily use of laxative within 1 month of screening.
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).

Primary Outcome Measures

Name	Time	Method
1.Reduction of abdominal discomfort / pain intensity â€“ assessed by physician (Baseline and Week 6, Week 10, and Week 12)	1.Reduction of abdominal discomfort / pain intensity â€“ assessed by physician (Baseline and Week 6, Week 10, and Week 12) \| 2. An increase of at least one complete spontaneous bowel movement per week from baseline; during the same week, for at least 4 out of 8 weeks of the intervention period.
2. An increase of at least one complete spontaneous bowel movement per week from baseline; during the same week, for at least 4 out of 8 weeks of the intervention period.	1.Reduction of abdominal discomfort / pain intensity â€“ assessed by physician (Baseline and Week 6, Week 10, and Week 12) \| 2. An increase of at least one complete spontaneous bowel movement per week from baseline; during the same week, for at least 4 out of 8 weeks of the intervention period.

Secondary Outcome Measures

Name	Time	Method
6. Evaluation of serum cytokines- Tumor necrosis factor alpha (TNF Î±), Interferon gamma (IFN Î³), Interleukin 6 (IL- 6), Interleukin 10 (IL-10) and Interleukin 12 (IL-12)	6.Baseline, Week 10
1.Overall change in severity of symptoms (Baseline, Week 6, Week 10)	2.Abdominal discomfort (Baseline, Week 6, Week 10)

Locations (2): Life Veda Treatment and Research Centre
🇮🇳
Mumbai, MAHARASHTRA, India
Nanal Clinic.
🇮🇳
Mumbai, MAHARASHTRA, India
Life Veda Treatment and Research Centre
🇮🇳Mumbai, MAHARASHTRA, India
DrAnirudh Tripathi
Principal investigator
91-9820180084
dranirudh_t@yahoo.com