Multi-Strain Probiotics Supplementation With Standard Care in Mild to Moderate Ulcerative Colitis
Recruiting · NCT06595719 · Interventional (participants receive a specific treatment) · Lead sponsor: National University of Malaysia
View the official record on ClinicalTrials.gov →Interventions studied
Multi-Strain ProbioticsPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Hospital Canselor Tuanku Muhriz UKM - Cheras, Kuala Lumpur, Malaysia