Multi-Strain Probiotics Supplementation With Standard Care in Mild to Moderate Ulcerative Colitis
Assessing Gut Microbiota, Mucosal Healing Markers, and Metabolites in Mild to Moderate Ulcerative Colitis Treated With Multi-Strain Probiotics
National University of Malaysia
124 participants
Feb 23, 2024
INTERVENTIONAL
Conditions
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 benefits when adequately supplied to the body, especially for gut wellness. In particular, for UC patients, gut dysbiosis is one of the contributing factors in their pathogenesis. Thus, the supplementation of probiotics in combination with standard treatment can potentially help in relieving symptoms as well as promoting mucosal healing for long-term remission.
Eligibility
Inclusion Criteria4
- 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 Criteria6
- 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.
Interventions
Each sachet of the multi-strain probiotics contain 30 billion CFU of 6 strains which includes Lactobacillus acidophilus BCMC®12130, Lactobacillus casei subsp BCMC®12313, Lactobacillus lactis BCMC®12451, Bifidobacterium bifidum BCMC®02290, Bifidobacterium infantis BCMC®02129, Bifidobacterium longum BCMC®02120
Replicate for multi-strain probiotics without any active ingredients
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06595719