Microbiota and Probiotic Therapy in Ulcerative Colitis Patients
NCT ID: NCT07180186
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2022-01-01
2024-05-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group I
Patients with ulcerative colitis in remission treated with oral mesalamine.
Mesalamine
Patients with ulcerative colitis in remission treated with oral mesalamine.
Group II
Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii).
Probiotics (Bacillus Clausii)
Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii).
Group III
Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii).
Mesalamine and probiotics (Bacillus Clausii)
Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii).
Group IV
Apparent healthy controls
No interventions assigned to this group
Interventions
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Mesalamine
Patients with ulcerative colitis in remission treated with oral mesalamine.
Probiotics (Bacillus Clausii)
Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii).
Mesalamine and probiotics (Bacillus Clausii)
Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Al Shaimaa Fathy El desouky
Assistant Lecturer of Tropical Medicine & Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.
Locations
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Tanta University
Tanta, El-Gharbia, Egypt
Countries
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Other Identifiers
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35074/11/21
Identifier Type: -
Identifier Source: org_study_id
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