RECRUITINGINTERVENTIONAL

Multi-Strain Probiotics Supplementation With Standard Care in Mild to Moderate Ulcerative Colitis

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DIETARY_SUPPLEMENT

Multi-Strain Probiotics

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

DIETARY_SUPPLEMENT

Placebo

Replicate for multi-strain probiotics without any active ingredients

Locations (1)

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, Malaysia