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Completed

NCT Number: NCT07180186

Microbiota and Probiotic Therapy in Ulcerative Colitis Patients

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

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Key information

Conditions

Microbiota Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Probiotic Therapy Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesalamine

Drug

Patients with ulcerative colitis in remission treated with oral mesalamine.

Probiotics (Bacillus Clausii)

Drug

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

Mesalamine and probiotics (Bacillus Clausii)

Drug

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

Primary outcomes

  1. Clinical Activity Index

    Time frame: 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 outcomes

  1. Body Mass Index

    Time frame: 12 months post-procedure

    Body mass index (BMI) was measured at the study start and every 3 months during the study follow-up period

  2. Gut Microbiota

    Time frame: 12 months post-procedure

    Gut Microbiota was measured.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Evaluation of Microbiota and Probiotic Therapy in Ulcerative Colitis Patients

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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