Status:
RECRUITING
Multi-Strain Probiotics Supplementation With Standard Care in Mild to Moderate Ulcerative Colitis
Lead Sponsor:
National University of Malaysia
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Probiotics are one of the adjunctive treatments that have been extensively explored for Ulcerative colitis (UC) disease management. Probiotics, a group of beneficial bacteria, can bring various health...
Detailed Description
Inflammatory bowel disease (IBD) has progressively risen globally, becoming more prevalent in recent years. Crohn's disease (CD) and UC are classified as two of IBD variations resulting in range of sy...
Eligibility Criteria
Inclusion
- Diagnosis of UC established by previous colonoscopy, with consistent histology, and clinical course.
- UC involving at least the rectosigmoid, actively confirmed by colonoscopy at the beginning of the study.
- Mild to moderate disease activity, defined as a PMS ranging from 3-8.
- Use of medication at least 4 weeks prior to study.
Exclusion
- Crohn's disease or pouchitis.
- Severe disease activity as defined in PMS, more than 8.
- Use of antibiotics within the last 2 weeks before study entry.
- Change in dose of medication within the last 4 weeks before study entry and throughout the 12-week study period.
- Use of probiotics preparation either prescribed or over the counter within 2 weeks before the study entry.
- Use of NSAIDs for 1 week before and throughout the 12-week study period.
Key Trial Info
Start Date :
February 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06595719
Start Date
February 23 2024
End Date
February 1 2026
Last Update
March 12 2025
Active Locations (1)
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1
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, Malaysia, 56000