Multi-Strain Probiotics Supplementation With Standard Care in Mild to Moderate Ulcerative Colitis
Not applicable · Testing Multi-Strain Probiotics · 1 site · National University of Malaysia
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Multi-Strain Probiotics (a dietary supplement) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 90
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 1 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 124 participants are expected to take part.
- Start date: 2024-02-23.
- Main results expected around 2026-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Malaysia.
Main thing being measured
- Gut microbiome analysis (12 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | National University of Malaysia |
| Enrollment | 124 (estimated) |
| Start date | 2024-02-23 |
| Primary completion (est.) | 2026-01 |
| First posted | 2024-09-19 |
| Last updated | 2025-03-12 |
| Official title | Assessing Gut Microbiota, Mucosal Healing Markers, and Metabolites in Mild to Moderate Ulcerative Colitis Treated With Multi-Strain Probiotics |
| ClinicalTrials.gov ID | NCT06595719 |
Interventions
- Multi-Strain Probiotics (Dietary Supplement)
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 - Placebo (Dietary Supplement)
Replicate for multi-strain probiotics without any active ingredients
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Canselor Tuanku Muhriz UKM | Cheras, Kuala Lumpur | Malaysia | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.