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

Phase

N/A

Condition

Lactose Intolerance

Colic

Gastrointestinal Diseases And Disorders

Treatment

SMT04 (M3XTRA)

Clinical Study ID

NCT06636513

IBSXtra

Ages 21-55
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Male or female, aged from 21 years to 70 years old
Meet the criteria of the Rome-III-definition of IBS with diarrhoea or mixedsubtypes, or functional diarrhoea Rome-III-definition: Abdominal pain or abdominaldiscomfort on minimum of three days per month during the last three months, startingat 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 ofIBS-D which requires more than 25% of the participant's stools to be loose andless than 25% hard and lumpy; subtype of IBS-M which the participant's stoolsmust be both hard and lumpy, as well as loose in consistency at least 25% ofthe time. Functional diarrhoea: The experience of loose or watery stoolswithout pain occurring in at least 75% of bowel movements for at least threemonths over the last six months.
Have the latest negative colonoscopy result within five years
Literate and can complete questionnaire
Written informed consent is obtained

Exclusion

Exclusion Criteria:

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

Study Design

SMT04 (M3XTRA)

March 20, 2024

December 31, 2026

Study Description

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. 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.

The central hypothesis is that SMT04 can modulate gut microbiota and improve clinical symptoms of subjects with IBS. This pilot study will evaluate the effect of SMT04 on improving IBS related scores and the longitudinal changes in gut microbiome.

The investigators hypothesize that SMT04 can modulate gut microbiota and improve the clinical symptoms of subjects with IBS. This pilot study will examine the effect of SMT04 probiotic supplementation on symptoms in IBS patients. The Rome III rather than Rome IV IBS diagnostic criteria will be used as it is less restrictive with less temporal fluctuation, and hence will be more suitable in an exploratory study. The study will also analyse the longitudinal changes in gut microbiome composition to correlate clinical outcomes with pathophysiological changes. This is a multi-centered trial, all data and samples from the study sites will be pooled together for analysis. If this pilot study demonstrates potential beneficial effect, the investigators will conduct a more definitive randomized controlled trial.

Connect with a study center

Dr Daphne Ang Shih Wen
Singapore, 529889
Singapore
Active - Recruiting

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