A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome (IBS)

NCT06636513 | Recruiting

• 1 other identifier: IBSXtra
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Probiotic supplements improve IBS symptoms through manipulation of the gut microbiota. Metabolites derived from microbiota metabolism and host-microbiota co-metabolism have an impact on host intracellular signalling pathways. Although probiotic supplements improve IBS symptoms, the precise composition of probiotics that can achieve optimal response remains unclear. SMT04 (M3XTRA, GenieBiome Limited, Hong Kong, China) is a novel product that is commercially available as a dietary supplement in Singapore. It consists of a patented probiotics blend of 5 probiotics (3 Bifidobacteria and 2 Streptococci with 12.5 billion CFU in 1 sachet). Probiotics preparation that included varying composition of Bifidobacteria and Streptococci strains had previously demonstrated efficacy in achieving symptom improvement in IBS patients. Streptococcus thermophilus, a component of the blended probiotics, significantly improved intestinal functional barrier in healthy subjects. Thus there is potential for SMT04, a dietary supplement, to be a treatment option for IBS patients. This is a multi-centered trial, all data and samples from the study sites will be pooled together for analysis.

Conditions

Irritable Bowel Syndrome

Keywords

probiotic; IBS; microbiota

Outcome Measures

Primary Outcomes (1)

• Change in microbiota (measured using Shannon index, Principal coordinate analysis, heatmaps) at month 3 after taking SMT04

  Assess change in microbiota (alpha diversity, beta diversity, taxonomic abundances) at Month 3

  3 months

Secondary Outcomes (2)

• The improvement of irritable bowel syndrome - severity scoring system (IBS-SSS) score at month 3 (Minimal symptoms 0-74; Mild symptoms 75-174; Moderate symptoms 175-299; Severe symptoms 300-500)

  3 months

• Improvement in gastrointestinal symptoms against baseline as measured by GI symptom assessment (improved, unchanged or worsened)

  3 months

Study Arms (1)

SMT04 Arm

EXPERIMENTAL

Each subject will take 1 sachet of SMT04 daily for 3 months.

Dietary Supplement: SMT04 (M3XTRA)

Interventions

SMT04 (M3XTRA) DIETARY_SUPPLEMENT

This is a pilot prospective single-arm, open-label clinical trial to assess the effect of the probiotic SMT04 (M3XTRA) on the gut microbiome and relief of IBS symptoms.

SMT04 Arm

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, aged from 21 years to 70 years old
• Meet the criteria of the Rome-III-definition of IBS with diarrhoea or mixed subtypes, or functional diarrhoea Rome-III-definition: Abdominal pain or abdominal discomfort on minimum of three days per month during the last three months, starting at least six months ago, and a minimum of two of the following criteria:
• Improvement of symptoms after defecation
• Start of symptoms in association with a change in stool frequency
• Start of symptoms in association with a change in stool consistency Subtype of IBS-D which requires more than 25% of the participant's stools to be loose and less than 25% hard and lumpy; subtype of IBS-M which the participant's stools must be both hard and lumpy, as well as loose in consistency at least 25% of the time. Functional diarrhoea: The experience of loose or watery stools without pain occurring in at least 75% of bowel movements for at least three months over the last six months.
• Have the latest negative colonoscopy result within five years
• Literate and can complete questionnaire
• Written informed consent is obtained

You may not qualify if:

• Known inflammatory bowel disease, lactose intolerance or other malabsorption syndromes, celiac disease, diabetes mellitus, thyroid dysfunction, cancer, immunodeficiency, autoimmune diseases, severe hepatic or renal insufficiency, other explainable causes of abdominal pain, diarrhoea or constipation
• Known operations involving small intestines and large intestines; or history of appendectomy, hysterectomy, and cholecystectomy in last 6 months.
• Known severe mental illnesses; unstable type or dose of psychiatric drugs within the last 3 months that will affect their judgement of study participation.
• History of use of prebiotics, probiotics, antibiotic therapy or anti-inflammatory drugs within the last 2 weeks
• Known current pregnancy or breast-feeding female

Sponsors & Collaborators

• Changi General Hospital: lead
• GenieBiome Limited: collaborator
• National University Hospital, Singapore: collaborator

Study Sites (1)

Dr Daphne Ang Shih Wen

Singapore, Singapore, 529889, Singapore

RECRUITING

Related Publications (2)

• Jafari E, Vahedi H, Merat S, Momtahen S, Riahi A. Therapeutic effects, tolerability and safety of a multi-strain probiotic in Iranian adults with irritable bowel syndrome and bloating. Arch Iran Med. 2014 Jul;17(7):466-70.

  PMID: 24979556 BACKGROUND

• Mezzasalma V, Manfrini E, Ferri E, Sandionigi A, La Ferla B, Schiano I, Michelotti A, Nobile V, Labra M, Di Gennaro P. A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation. Biomed Res Int. 2016;2016:4740907. doi: 10.1155/2016/4740907. Epub 2016 Aug 9.

  PMID: 27595104 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Daphne Shih Wen Ang

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Feng Tao

CONTACT

+65-64267815; Chunfeng_Tao@cgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: This is a pilot prospective single-arm, open-label clinical trial to assess the effect of the probiotic SMT04 (M3XTRA) on IBS symptoms.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: October 10, 2024
• Study Start: March 20, 2024
• Primary Completion: May 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)