Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636513
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
A Single-arm Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome IBS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-arm Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome IBS
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 125 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None