A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome (IBS)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chun Feng Tao
- Phone Number: +65-64267815
- Email: Chunfeng_Tao@cgh.com.sg
Study Locations
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Singapore, Singapore, 529889
- Recruiting
- Dr Daphne Ang Shih Wen
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Contact:
- Siew Yoon Yap
- Phone Number: +65-68502935
- Email: yap.siew.yoon@singhealth.com.sg
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Contact:
- Shih wen Daphne Ang, Dr
- Phone Number: +65-69365722
- Email: daphne.ang.s.w@singhealth.com.sg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 mixed subtypes, or functional diarrhoea Rome-III-definition: Abdominal pain or abdominal discomfort on minimum of three days per month during the last three months, starting at 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 of IBS-D which requires more than 25% of the participant's stools to be loose and less than 25% hard and lumpy; subtype of IBS-M which the participant's stools must be both hard and lumpy, as well as loose in consistency at least 25% of the time. Functional diarrhoea: The experience of loose or watery stools without pain occurring in at least 75% of bowel movements for at least three months 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 Criteria:
- Known inflammatory bowel disease, lactose intolerance or other malabsorption syndromes, celiac disease, diabetes mellitus, thyroid dysfunction, cancer, immunodeficiency, autoimmune diseases, severe hepatic or renal insufficiency, other explainable causes of abdominal pain, diarrhoea or constipation
- Known operations involving small intestines and large intestines; or history of appendectomy, hysterectomy, and cholecystectomy in last 6 months.
- Known severe mental illnesses; unstable type or dose of psychiatric drugs within the last 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-inflammatory drugs within the last 2 weeks
- Known current pregnancy or breast-feeding female
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: SMT04 Arm
Each subject will take 1 sachet of SMT04 daily for 3 months.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in microbiota (measured using Shannon index, Principal coordinate analysis, heatmaps) at month 3 after taking SMT04
Time Frame: 3 months
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Assess change in microbiota (alpha diversity, beta diversity, taxonomic abundances) at Month 3
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The improvement of irritable bowel syndrome - severity scoring system (IBS-SSS) score at month 3 (Minimal symptoms 0-74; Mild symptoms 75-174; Moderate symptoms 175-299; Severe symptoms 300-500)
Time Frame: 3 months
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Examine improvement of IBS-SSS score at Month 3
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3 months
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Improvement in gastrointestinal symptoms against baseline as measured by GI symptom assessment (improved, unchanged or worsened)
Time Frame: 3 months
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Change in gastrointestinal symptoms (presence/ absence of nausea, vomiting, abdominal pain, bloating, diarrhea, constipation and other symptoms) at Month 3
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daphne Shih Wen Ang, Changi General Hospital
Publications and helpful links
General Publications
- Jafari E, Vahedi H, Merat S, Momtahen S, Riahi A. Therapeutic effects, tolerability and safety of a multi-strain probiotic in Iranian adults with irritable bowel syndrome and bloating. Arch Iran Med. 2014 Jul;17(7):466-70.
- Mezzasalma V, Manfrini E, Ferri E, Sandionigi A, La Ferla B, Schiano I, Michelotti A, Nobile V, Labra M, Di Gennaro P. A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation. Biomed Res Int. 2016;2016:4740907. doi: 10.1155/2016/4740907. Epub 2016 Aug 9. Erratum In: Biomed Res Int. 2019 Apr 9;2019:9042956. doi: 10.1155/2019/9042956.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBSXtra
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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