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

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.

NCT Number	NCT06636513
Lead Sponsor	Changi General Hospital Collaborators: GenieBiome Limited, National University Hospital, Singapore
Conditions	Irritable Bowel Syndrome
Enrollment	40 participants
Start Date	2024-03-20
Primary Completion	2025-05-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-12