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

NCT06595719 | Recruiting DMC

• 1 other identifier: UKM PPI/111/8/JEP-2023-852
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Probiotics; Inflammatory Bowel Disease; Gut microbiota

Outcome Measures

Primary Outcomes (7)

• Gut microbiome analysis

  The composition, diversity, and core microbiome of the gut bacterial community were identified via 16S rRNA sequencing and compared before and after taking multi-strain probiotics or placebo.

  12 weeks

• Faecal Calprotectin Level

  Level of faecal calprotectin (mg/kg) measured before and after treatment with multi-strain probiotics or placebo, indicating levels of intestinal inflammation.

  12 weeks

• C-reactive Protein (CRP) Level

  Level of CRP (mg/dl) measured before and after treatment with multi-strain probiotics or placebo, reflecting changes in systemic inflammation.

  12 weeks

• Erythrocyte Sedimentation Rate (ESR) Level

  Rate of erythrocyte sedimentation (mm/hr) measured before and after treatment with multi-strain probiotics or placebo, as a marker of inflammation.

  12 weeks

• Change in White Blood Cell (WBC) Count

  Number of participants with changes in WBC count (x10\^9/L) measured before and after treatment with multi-strain probiotics or placebo, to assess immune response and inflammation levels.

  12 weeks

• Change in Serum Metabolite Profile

  Identification and quantification of serum metabolites via Liquid Chromatography-Mass Spectrometry (LC-MS) before and after treatment with multi-strain probiotics or placebo. The changes in metabolite concentrations will be compared to assess the metabolic response to the intervention.

  12 weeks

• Change in Proinflammatory Cytokine Gene Expression

  Quantification of IL5, IL6, IL13, IL33, and TNFα gene expression using quantitative PCR (qPCR) before and after treatment with multi-strain probiotics or placebo. The changes in gene expression levels will be compared to evaluate the impact on proinflammatory cytokines.

  12 weeks

Secondary Outcomes (5)

• Partial Mayo score (PMS)

  12 weeks

• International Physical Activity Questionnaire (IPAQ)

  12 weeks

• Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  12 weeks

• Three Days Food Record

  12 weeks

• Diet History Questionnaire

  12 weeks

Study Arms (2)

Probiotics with standard care

EXPERIMENTAL

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.

Dietary Supplement: Multi-Strain Probiotics

Placebo with standard care

PLACEBO COMPARATOR

62 mild to moderate UC patients were supplemented with placebo, containing no active bacteria strains for 12 weeks

Dietary Supplement: Placebo

Interventions

Multi-Strain Probiotics DIETARY_SUPPLEMENT

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

Probiotics with standard care

Placebo DIETARY_SUPPLEMENT

Replicate for multi-strain probiotics without any active ingredients

Placebo with standard care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Norfilza M Mokhtar, MD, MMedSci, PhD

CONTACT

+60391458610; norfilza@ppukm.ukm.edu.my

Raja Affendi Raja Ali, MBBChBaO,MD,MMedSci,MBA,CCST

CONTACT

+60391455202; draffendi@ppukm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: February 23, 2024
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)