Microbiota and Probiotic Therapy in Ulcerative Colitis Patients

NCT07180186 | Completed

• 1 other identifier: 35074/11/21
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Microbiota; Probiotic Therapy; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Clinical Activity Index

  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)

  12 months post-procedure

Secondary Outcomes (2)

• Body Mass Index

  12 months post-procedure

• Gut Microbiota

  12 months post-procedure

Study Arms (4)

Group I

Patients with ulcerative colitis in remission treated with oral mesalamine.

Drug: Mesalamine

Group II

Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii).

Drug: Probiotics (Bacillus Clausii)

Group III

Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii).

Drug: Mesalamine and probiotics (Bacillus Clausii)

Group IV

Apparent healthy controls

Interventions

Mesalamine DRUG

Patients with ulcerative colitis in remission treated with oral mesalamine.

Group I

Probiotics (Bacillus Clausii) DRUG

Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii).

Group II

Mesalamine and probiotics (Bacillus Clausii) DRUG

Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii).

Group III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is a prospective study that will be carried in Tanta University Hospital, Tropical Medicine and Infectious Diseases Department.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine; Probiotics

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Tropical Medicine & Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: January 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)