Microbiota and Probiotic Therapy in Ulcerative Colitis Patients

Completed

• Conditions: Microbiota; Probiotic Therapy; Ulcerative Colitis
• Interventions: Drug: Mesalamine; Drug: Probiotics (Bacillus Clausii); Drug: Mesalamine and probiotics (Bacillus Clausii)

• Registration Number: NCT07180186
• Lead Sponsor: Tanta University

Brief Summary

This study aimed to evaluate the role of microbiota and probiotics in Egyptian patients with ulcerative colitis.

Detailed Description

Inflammatory bowel disease (IBD) is a group of chronic diseases that significantly affects patients' quality of life and is mainly represented by Crohn's disease (CD) and ulcerative colitis (UC).

The microbiome is a key contributor to various fundamental aspects of human health, including host metabolism, infection, and the immune response.

Changes in microbiome composition have been linked to complex multifactorial diseases, e.g., type 2 diabetes, metabolic syndrome, and non-alcoholic fatty liver syndrome, as well as inflammatory bowel disease (IBD).

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients more than 18 years.
• Patients with ulcerative colitis in remission as assessed by the clinical activity index (CAI) ≤ 4, endoscopic index (EI) ≤ 4, and no signs of acute inflammation on histological examination.

Exclusion Criteria

• Active ulcerative colitis.
• Cardiac, hepatic, or renal disease.
• Pregnancy.
• History of major colonic surgery.
• Patients with any malignancy.
• Previously taking other probiotics.
• Use of steroids within the last 4 weeks before study entry.
• Use of antibiotics within the last 2 weeks before study entry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I	Mesalamine	Patients with ulcerative colitis in remission treated with oral mesalamine.
Group II	Probiotics (Bacillus Clausii)	Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii).
Group III	Mesalamine and probiotics (Bacillus Clausii)	Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii).

Primary Outcome Measures

Name	Time	Method
Clinical Activity Index	12 months post-procedure	The clinical activity index (CAI) is a tool that assesses disease activity in patients with ulcerative colitis. Seven clinical features are evaluated, with the total index score ranging from 0 to 25: 0 to 4 inactive (remission); 5 to 10 mild activity; 11 to 17 moderate activity; and ≥ 18 high activity.; CAI was measured at the study start and every 3 months through the follow up period (1year)

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	12 months post-procedure	Body mass index (BMI) was measured at the study start and every 3 months during the study follow-up period
Gut Microbiota	12 months post-procedure	Gut Microbiota was measured.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt