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

A Study to Assess the Effect of a Probiotic Strains (Bacillus clausii) on Gut Microbiota and Mucosal Immunity in Inflammatory Bowel Disease - EPMIBD

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/11/022087

Enrollment

100

Registered

2019-11-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Casule of Bacillus clausii UBBC07 (Probiotic CFU - 2X109 per capsule): Dose - Probiotic CFU - 2X109 per capsule Frequency- BD (One probiotic capsule twice in day) (Probiotic CFU - 2X

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Survival and colonization of Bacillus strains (B coagulans Unique IS2 and B clausii UBBC07)in the IBD patients. 2. Modulation of gut microbiota in the IBD patients. 3.Effect of B coagulans Unique IS2 and B clausii UBBC07 in the symptoms in IBD patients. 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	—

Measure

Time frame

1. Survival and colonization of Bacillus strains (B coagulans Unique IS2 and B clausii UBBC07)in the IBD patients. 2. Modulation of gut microbiota in the IBD patients. 3.Effect of B coagulans Unique IS2 and B clausii UBBC07 in the symptoms in IBD patients. 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

Measure	Time frame
Clinical improvement Change in Gut Microbial diversityTimepoint: 18 Months	—

Countries

India

Contacts

Public ContactDr Rama Chaudhry

AIIMS

drramach@gmail.com01126593475

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026