Actively Recruiting
A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome (IBS)
Led by Changi General Hospital · Updated on 2025-02-12
40
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
Sponsors
C
Changi General Hospital
Lead Sponsor
G
GenieBiome Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome (IBS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged from 21 years to 70 years old
- Meet Rome III criteria for IBS with diarrhea or mixed subtypes, or functional diarrhea
- Have a negative colonoscopy result within the last five years
- Literate and able to complete questionnaires
- Provide written informed consent
You will not qualify if you...
- Known inflammatory bowel disease, lactose intolerance, malabsorption syndromes, celiac disease, diabetes mellitus, thyroid dysfunction, cancer, immunodeficiency, autoimmune diseases, severe liver or kidney failure, or other explainable causes of abdominal pain, diarrhea, or constipation
- History of operations on small or large intestines; or appendectomy, hysterectomy, or cholecystectomy within last 6 months
- Severe mental illness or unstable psychiatric medication use in last 3 months affecting judgment
- Active infection at time of inclusion
- Use of prebiotics, probiotics, antibiotics, or anti-inflammatory drugs within last 2 weeks
- Current pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dr Daphne Ang Shih Wen
Singapore, Singapore, Singapore, 529889
Actively Recruiting
Research Team
C
Chun Feng Tao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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