Microbiota, Probiotic Therapy, Ulcerative Colitis
Conditions
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).
Interventions
DRUGMesalamine
Patients with ulcerative colitis in remission treated with oral mesalamine.
DRUGProbiotics (Bacillus Clausii)
Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii).
DRUGMesalamine and probiotics (Bacillus Clausii)
Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii).
Sponsors
Tanta University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed