Irritable Bowel SyndromeNCT06636513
A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome (IBS)
A study testing SMT04 (M3XTRA) in people with Irritable Bowel Syndrome, run by Changi General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- SMT04 (M3XTRA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Dr Daphne Ang Shih Wen
Singapore, Singapore, 529889
Shih wen Daphne Ang, Dr, +65-69365722, daphne.ang.s.w@singhealth.com.sg
Siew Yoon Yap, +65-68502935, yap.siew.yoon@singhealth.com.sg
About this study
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.
Read the 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
- Being tested
- SMT04 (M3XTRA)
- Keywords
- probiotic, IBS, microbiota
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMT04 (M3XTRA)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| SMT04 Arm | Experimental | Each subject will take 1 sachet of SMT04 daily for 3 months. Receives: Dietary Supplement: SMT04 (M3XTRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiota (measured using Shannon index, Principal coordinate analysis, heatmaps) at month 3 after taking SMT04
Assess change in microbiota (alpha diversity, beta diversity, taxonomic abundances) at Month 3
Measured: 3 months
Secondary outcomes (2)
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)
Examine improvement of IBS-SSS score at Month 3
Measured: 3 months
Improvement in gastrointestinal symptoms against baseline as measured by GI symptom assessment (improved, unchanged or worsened)
Change in gastrointestinal symptoms (presence/ absence of nausea, vomiting, abdominal pain, bloating, diarrhea, constipation and other symptoms) at Month 3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start20 Mar 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot prospective single-arm, open-label clinical trial to assess the effect of the probiotic SMT04 (M3XTRA) on IBS symptoms.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GenieBiome Limited, National University Hospital, Singapore
- Responsible party
- Principal investigator, Ang Shih Wen Daphne, Changi General Hospital
- Investigators
- Daphne Shih Wen Ang, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636513
- Sponsor's protocol ID
- IBSXtra
- Status last verified
- Feb 2025
- First submitted
- 20 Aug 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24979556Mezzasalma 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.
PubMed 27595104
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Trial to Evaluate the Effect of SMT04 in Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT06636513
- Acronym / sponsor ID
- IBSXtra
- Conditions
- Irritable Bowel Syndrome
- Keywords
- probiotic, IBS, microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- GenieBiome Limited, National University Hospital, Singapore
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot prospective single-arm, open-label clinical trial to assess the effect of the probiotic SMT04 (M3XTRA) on IBS symptoms.
| Arm | Type | Receives |
|---|---|---|
| SMT04 Arm | Experimental | Dietary Supplement: SMT04 (M3XTRA)Each subject will take 1 sachet of SMT04 daily for 3 months. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- Have the latest negative colonoscopy result within five years
- Literate and can complete questionnaire
- Written informed consent is obtained
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | SMT04 Arm |
Primary outcome
Change in microbiota (measured using Shannon index, Principal coordinate analysis, heatmaps) at month 3 after taking SMT04
Time frame: 3 months
Assess change in microbiota (alpha diversity, beta diversity, taxonomic abundances) at Month 3
2 secondary outcomes
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
Improvement in gastrointestinal symptoms against baseline as measured by GI symptom assessment (improved, unchanged or worsened)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 24979556Jafari 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.
- Background: PubMed 27595104Mezzasalma 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daphne Shih Wen Ang principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMT04 (M3XTRA) in people with Irritable Bowel Syndrome, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun Feng Tao (+65-64267815, Chunfeng_Tao@cgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microbiota (measured using Shannon index, Principal coordinate analysis, heatmaps) at month 3 after taking SMT04 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06636513, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.