Probiotics with standard care for mild to moderate ulcerative colitis
Assessing Gut Microbiota, Mucosal Healing Markers, and Metabolites in Mild to Moderate Ulcerative Colitis Treated With Multi-Strain Probiotics
NA · National University of Malaysia · NCT06595719
This study is testing if adding multi-strain probiotics to standard treatment can help people with mild to moderate ulcerative colitis feel better and stay in remission.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | National University of Malaysia (other) |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Trial ID | NCT06595719 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of multi-strain probiotics as an adjunctive treatment for patients with mild to moderate ulcerative colitis (UC). It aims to assess whether probiotics can enhance the efficacy of standard care by restoring gut microbiota balance and promoting mucosal healing. Participants will receive either the probiotics or a placebo alongside their usual medications, with their symptoms and disease activity monitored over a 12-week period. The study seeks to address the ongoing challenges faced by UC patients in achieving and maintaining remission.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with mild to moderate ulcerative colitis who have not recently used probiotics or antibiotics.
Not a fit: Patients with severe ulcerative colitis or those with Crohn's disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, effective option for managing symptoms and improving quality of life for patients with ulcerative colitis.
How similar studies have performed: Previous studies have shown promising results for probiotics in managing ulcerative colitis, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cheras, Kuala Lumpur
- Hospital Canselor Tuanku Muhriz UKM — Cheras, Kuala Lumpur, Malaysia (RECRUITING)
Study contacts
- Study coordinator: Norfilza M Mokhtar, MD, MMedSci, PhD
- Email: norfilza@ppukm.ukm.edu.my
- Phone: +60391458610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ulcerative Colitis, Probiotics, Inflammatory Bowel Disease, Gut microbiota