Effect of Probiotic (Bacillus Strains -B coagulans Unique IS2 and B clausii UBBC07) in Inflammatory Bowel Disease Patients

Phase 2

• Conditions: Health Condition 1: null- Inflammatory Bowel Disease -Ulcerative Colitis and Crohns diseaseHealth Condition 2: K638- Other specified diseases of intestine

• Registration Number: CTRI/2019/11/022087
• Lead Sponsor: nique Biotech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Adult patient clinically diagnosed for Ulcerative Colitis (UC)

Adult patient clinically diagnosed for Crohnâ??s Disease (CD)

Patient of UC or CD of either sex of the age range from 20-60 year

Patient of UC or CD who is ready to participate in the study and giving written consent

Patient of UC or CD who is visiting to OPD or admitted in AIIMS for treatment

Exclusion Criteria

Patient of either sex of below and above the defined age range of 20-60 year

Patient not ready to participate in the study and giving written consent

Patient diagnosed for any kind of carcinoma

Patient diagnosed for any other gastrointestinal disease

Patient suffering from Immunodeficiency disorder

Patient is taking any Probiotic drug / or consumed probiotic drug in last three month

Orally nil patient / Not taking food through oral route

Patient underwent any kind of gastrointestinal surgery in last three month

Patient with surgical removal of the any part of gastrointestinal tract

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Survival and colonization of Bacillus strains (B coagulans Unique IS2 and B clausii UBBC07)in the IBD patients. <br/ ><br>2. Modulation of gut microbiota in the IBD patients. <br/ ><br>3.Effect of B coagulans Unique IS2 and B clausii UBBC07 in the symptoms in IBD patients. <br/ ><br>4. Effect of Probiotic strain B coagulans Unique IS2 and B clausii UBBC07 on Pro and Anti-inflammatory cytokines in the IBD patients.Timepoint: Before and After one month of Intervention

Secondary Outcome Measures

Name	Time	Method
Clinical improvement <br/ ><br>Change in Gut Microbial diversityTimepoint: 18 Months