Assessing Gut Microbiota, Mucosal Healing Markers, and Metabolites in Mild to Moderate Ulcerative Colitis Treated With Multi-Strain Probiotics

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Malaysia
Hospital Canselor Tuanku Muhriz UKM
RECRUITING
Cheras
Contact Information
Primary
Norfilza M Mokhtar, MD, MMedSci, PhD
norfilza@ppukm.ukm.edu.my
+60391458610
Backup
Raja Affendi Raja Ali, MBBChBaO,MD,MMedSci,MBA,CCST
draffendi@ppukm.ukm.edu.my
+60391455202
Time Frame
Start Date: 2024-02-23
Estimated Completion Date: 2026-02
Participants
Target number of participants: 124
Treatments
Experimental: Probiotics with standard care
62 mild to moderate UC patients were supplemented with multi-strain probiotics consisting of 6 active strains from Bifidobacterium and Lactobacillus species for 12 weeks.
Placebo_comparator: Placebo with standard care
62 mild to moderate UC patients were supplemented with placebo, containing no active bacteria strains for 12 weeks
Sponsors
Leads: National University of Malaysia

This content was sourced from clinicaltrials.gov

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