NCT06595719 Multi-Strain Probiotics Supplementation With Standard Care in Mild to Moderate Ulcerative Colitis
| NCT ID | NCT06595719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University of Malaysia |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2024-02-23 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 124 participants in total. It began in 2024-02-23 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06595719 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06595719 currently recruiting?
Yes, NCT06595719 is actively recruiting participants. Contact the research team at norfilza@ppukm.ukm.edu.my for enrollment information.
Where is the NCT06595719 trial being conducted?
This trial is being conducted at Cheras, Malaysia.
Who is sponsoring the NCT06595719 clinical trial?
NCT06595719 is sponsored by National University of Malaysia. The trial plans to enroll 124 participants.
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