NCT06595719Recruiting
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 3 Sept 2024
- Start date
- 23 Feb 2024
- Primary completion date
- Jan 2026
- Lead sponsor
- National University of Malaysia
- Diseases
- Ulcerative colitis
- NCT number
- NCT06595719
What you commit to
- Study type: Interventional
- Planned participants: 124
- From 23 Feb 2024 to the primary completion date, Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Crohn's disease or pouchitis.
- Severe disease activity as defined in PMS, more than 8.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Canselor Tuanku Muhriz UKM Coordinator of this site? Confirm its status | Cheras | Malaysia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.