Probiotics with standard care for mild to moderate ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.