NCT06636513

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Changi General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SMT04 (M3XTRA)	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.

Timeline

• Start date: 2024-03-20
• Primary completion: 2025-05-31
• Completion: 2026-12-31
• First posted: 2024-10-10
• Last updated: 2025-02-12

Locations

1 site across 1 country: Singapore