IBS (Irritable Bowel Syndrome)NCT07699926
Efficacy of PosBion® Postbiotic Supplementation in Adults With Irritable Bowel Syndrome
A study testing Postbiotic supplementation in people with IBS (Irritable Bowel Syndrome) and IBD (Inflammatory Bowel Disease), run by My Myracle Sdn.Bhd at 1 site in Malaysia.
Trial summary
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain and altered bowel habits, often associated with impaired intestinal barrier function, low-grade inflammation, and dysregulation of the gut-brain axis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBS (Irritable Bowel Syndrome), IBD (Inflammatory Bowel Disease), Gut Health
- What is being tested?
- Postbiotic supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experienced one or more symptoms consistent with irritable bowel syndrome (IBS), including:
- Stomach pain or abdominal cramps
- Bloating
- Excessive gas
- Diarrhoea
- Constipation (or alternating diarrhoea and constipation)
Show all 11Show fewer
- Mucus in stool
- Urgency to defecate
- Sensation of incomplete bowel evacuation
- Willing and able to comply with all study procedures and scheduled visits.
- Provided written informed consent before study participation.
Who cannot join
- History of chronic or serious medical conditions, including but not limited to diabetes mellitus, cardiovascular disease, chronic kidney disease, cancer, or chronic respiratory disease.
- Current use of supplements intended to improve gut health.
- Current use of antibiotics or antiviral medications.
- Current use of probiotic, prebiotic, or postbiotic supplements.
- Major surgery within the previous 6 months.
- Pregnant or breastfeeding women.
- Known allergy or hypersensitivity to any ingredient of the investigational product.
- Any condition that, in the opinion of the investigators, could interfere with study participation, compliance, or interpretation of the study results.
Trial locations and contacts
1 site in 1 country.
About this study
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain and altered bowel habits, often associated with impaired intestinal barrier function, low-grade inflammation, and dysregulation of the gut-brain axis. Postbiotics have emerged as a promising therapeutic approach due to their immunomodulatory, anti-inflammatory, and gut barrier-protective properties.
This completed single-arm, open-label clinical study evaluated the efficacy of PosBion® postbiotic supplementation in adults with IBS over a 12-week intervention period. The study assessed changes in IBS symptom severity, quality of life, gastrointestinal health, inflammatory biomarkers, intestinal barrier integrity, mucosal immunity, oxidative stress, and gut-brain axis biomarkers using validated questionnaires and salivary biomarker analyses.
Read the detailed description
Irritable bowel syndrome (IBS) is one of the most prevalent disorders of gut-brain interaction, affecting millions of individuals worldwide and substantially impairing quality of life. Increasing evidence suggests that IBS is associated with intestinal dysbiosis, impaired intestinal barrier function, microbial translocation, low-grade inflammation, oxidative stress, altered mucosal immunity, and dysregulation of the gut-brain axis. These interconnected mechanisms represent important therapeutic targets for nutritional interventions.
Postbiotics, consisting of inactivated microorganisms and their bioactive components, have attracted increasing attention due to their safety, stability, and potential health benefits. Experimental and clinical studies suggest that postbiotics may improve intestinal homeostasis by strengthening epithelial barrier integrity, modulating immune responses, suppressing intestinal inflammation, and regulating host-microbiota interactions.
This completed prospective, single-arm, open-label clinical study investigated the efficacy of PosBion® postbiotic supplementation in adults with IBS. Fifty-five subjects were enrolled, of whom fifty completed the 12-week intervention. Subjects consumed two sachets of PosBion® daily throughout the study period.
Clinical efficacy was evaluated using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire, and a gastrointestinal health visual analogue scale (GI Health VAS). To investigate the potential mechanisms underlying the intervention, serial saliva samples were collected at baseline and during follow-up visits for biomarker analyses.
Inflammatory responses were assessed by measuring salivary calprotectin, interleukin-1β (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), lactoferrin, and myeloperoxidase (MPO). Intestinal barrier integrity and intestinal permeability were evaluated using salivary zonulin, lipopolysaccharide (LPS), and lipopolysaccharide-binding protein (LBP). Mucosal immune function was assessed using secretory immunoglobulin A (sIgA), while oxidative stress was evaluated by measuring salivary malondialdehyde (MDA). Gut-brain axis responses were assessed using salivary cortisol and serotonin.
The study aimed to determine whether PosBion® supplementation could improve clinical outcomes in IBS while modulating biomarkers associated with intestinal inflammation, barrier integrity, mucosal immunity, oxidative stress, and gut-brain axis function, thereby providing mechanistic evidence supporting the therapeutic potential of postbiotics in IBS.
- Being tested
- Postbiotic supplementation
- Keywords
- Irritable Bowel Syndrome, Postbiotic, PosBion®, Lactobacillus plantarum, Gut Health, Functional Gastrointestinal Disorder
- Medical subject headings
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postbiotic supplementationDietary supplement
Also called PosBion®
PosBion® is a dietary postbiotic supplement containing inactivated Lactobacillus plantarum RS5 (2,500 mg) and Lactobacillus plantarum RI11 (2,500 mg) per sachet. Subjects consumed two sachets orally once daily for 12 weeks. The intervention was evaluated for its effects on IBS symptoms, quality of life, gastrointestinal health, intestinal inflammation, intestinal barrier integrity, mucosal immunity, oxidative stress, and gut-brain axis biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| PosBion® Postbiotic Supplementation | Experimental | Subjects received PosBion® postbiotic supplementation for 12 weeks. Each sachet contained Lactobacillus plantarum RS5 (2,500 mg) and Lactobacillus plantarum RI11 (2,500 mg). Subjects were instructed to consume two sachets daily throughout the intervention period. Clinical assessments and saliva samples were collected at baseline and at Weeks 4, 8, and 12 to evaluate changes in IBS symptoms, quality of life, gastrointestinal health, inflammatory biomarkers, intestinal barrier function, mucosal immunity, oxidative stress, and gut-brain axis biomarkers. Receives: Dietary Supplement: Postbiotic supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Score
IBS-related quality of life was assessed using the 34-item Irritable Bowel Syndrome Quality of Life questionnaire. Raw item scores were transformed to a total score ranging from 0 to 100. Higher scores indicate better IBS-related quality of life and a better outcome.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) Score
Irritable bowel syndrome symptom severity was assessed using the 5-item Irritable Bowel Syndrome Symptom Severity Scale. The scale evaluates abdominal pain severity, abdominal pain frequency, abdominal distension, dissatisfaction with bowel habits, and interference with daily life. The total score ranges from 0 to 500, with higher scores indicating more severe IBS symptoms and a worse outcome.
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (14)
Change in Gastrointestinal Health Visual Analogue Scale (GI Health VAS)
To evaluate changes in subjects' self-perceived gastrointestinal health using a visual analogue scale, ranging from 0 to 10. Zero is equivalent to the worst possible GI health and 10 indicates the best possible GI health.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Calprotectin Concentration
Salivary calprotectin concentration was measured using enzyme-linked immunosorbent assay (ELISA) as a marker of intestinal inflammation and neutrophil activation.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Interleukin-1β (IL-1β) Concentration
Salivary IL-1β concentration was measured using ELISA as a marker of pro-inflammatory cytokine activity.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Interleukin-6 (IL-6) Concentration
Salivary IL-6 concentration was measured using ELISA as a marker of inflammatory responses.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Interleukin-8 (IL-8) Concentration
Salivary IL-8 concentration was measured using ELISA as a marker of neutrophil recruitment and intestinal inflammatory responses.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Lactoferrin Concentration
Salivary lactoferrin concentration was measured using ELISA as a marker of neutrophil activation and intestinal inflammation.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Myeloperoxidase (MPO) Concentration
Salivary myeloperoxidase concentration was measured using ELISA as a marker of neutrophil-derived oxidative inflammatory activity.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Zonulin Concentration
Salivary zonulin concentration was measured using ELISA as a marker of intestinal barrier integrity and intestinal permeability.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Lipopolysaccharide (LPS) Concentration
Salivary lipopolysaccharide concentration was measured using ELISA to evaluate microbial endotoxin exposure associated with intestinal permeability.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Lipopolysaccharide-Binding Protein (LBP) Concentration
Salivary lipopolysaccharide-binding protein concentration was measured using ELISA as an indicator of host response to bacterial endotoxin and microbial translocation.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Secretory Immunoglobulin A (sIgA) Concentration
Salivary secretory immunoglobulin A concentration was measured using ELISA to assess mucosal immune function.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Malondialdehyde (MDA) Concentration
Salivary malondialdehyde concentration was measured using ELISA as a marker of lipid peroxidation and oxidative stress.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Cortisol Concentration
Salivary cortisol concentration was measured using ELISA to assess physiological stress responses associated with the gut-brain axis.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Serotonin Concentration
Salivary serotonin concentration was measured using ELISA as a biomarker of gut-brain axis function and neurotransmitter regulation.
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Jan 2026
- Primary completion31 May 2026
- Study completion30 Jun 2026
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 IBS (Irritable Bowel Syndrome)Studies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This was a single-arm, prospective, open-label interventional study in which all enrolled subjects received PosBion® postbiotic supplementation for 12 weeks. Clinical assessments and salivary biomarker measurements were performed at baseline and at Weeks 4, 8, and 12 to evaluate changes over time within the same cohort.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- My Myracle Sdn.Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UCSI University
- Responsible party
- Sponsor
- Investigators
- Chung Keat Tan, PhD, Principal investigator, UCSI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699926
- Sponsor's protocol ID
- IEC-2025-FMHS-0017
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published articles, including demographic characteristics, clinical outcome measures, questionnaire scores, and biomarker data, will be made available to qualified researchers upon reasonable request. Requests must be accompanied by a scientifically sound research proposal and will be subject to approval by the principal investigator and study sponsor to ensure participant confidentiality and compliance with applicable ethical and institutional requirements. Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.
Publications
Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067.
PubMed 35014601Roth B, Nseir M, Jeppsson H, D'Amato M, Sundquist K, Ohlsson B. A Starch- and Sucrose-Reduced Diet Has Similar Efficiency as Low FODMAP in IBS-A Randomized Non-Inferiority Study. Nutrients. 2024 Sep 9;16(17):3039. doi: 10.3390/nu16173039.
PubMed 39275354
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of PosBion® Postbiotic Supplementation in Adults With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07699926
- Acronym / sponsor ID
- IEC-2025-FMHS-0017
- Keywords
- Irritable Bowel Syndrome, Postbiotic, PosBion®, Lactobacillus plantarum, Gut Health, Functional Gastrointestinal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- My Myracle Sdn.BhdIndustry (pharma, biotech, devices)
- Collaborators
- UCSI University
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 13 Jul 2026 (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.
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain and altered bowel habits, often associated with impaired intestinal barrier function, low-grade inflammation, and dysregulation of the gut-brain axis. Postbiotics have emerged as a promising therapeutic approach due to their immunomodulatory, anti-inflammatory, and gut barrier-protective properties.
This completed single-arm, open-label clinical study evaluated the efficacy of PosBion® postbiotic supplementation in adults with IBS over a 12-week intervention period. The study assessed changes in IBS symptom severity, quality of life, gastrointestinal health, inflammatory biomarkers, intestinal barrier integrity, mucosal immunity, oxidative stress, and gut-brain axis biomarkers using validated questionnaires and salivary biomarker analyses.
Detailed description
Irritable bowel syndrome (IBS) is one of the most prevalent disorders of gut-brain interaction, affecting millions of individuals worldwide and substantially impairing quality of life. Increasing evidence suggests that IBS is associated with intestinal dysbiosis, impaired intestinal barrier function, microbial translocation, low-grade inflammation, oxidative stress, altered mucosal immunity, and dysregulation of the gut-brain axis. These interconnected mechanisms represent important therapeutic targets for nutritional interventions.
Postbiotics, consisting of inactivated microorganisms and their bioactive components, have attracted increasing attention due to their safety, stability, and potential health benefits. Experimental and clinical studies suggest that postbiotics may improve intestinal homeostasis by strengthening epithelial barrier integrity, modulating immune responses, suppressing intestinal inflammation, and regulating host-microbiota interactions.
This completed prospective, single-arm, open-label clinical study investigated the efficacy of PosBion® postbiotic supplementation in adults with IBS. Fifty-five subjects were enrolled, of whom fifty completed the 12-week intervention. Subjects consumed two sachets of PosBion® daily throughout the study period.
Clinical efficacy was evaluated using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire, and a gastrointestinal health visual analogue scale (GI Health VAS). To investigate the potential mechanisms underlying the intervention, serial saliva samples were collected at baseline and during follow-up visits for biomarker analyses.
Inflammatory responses were assessed by measuring salivary calprotectin, interleukin-1β (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), lactoferrin, and myeloperoxidase (MPO). Intestinal barrier integrity and intestinal permeability were evaluated using salivary zonulin, lipopolysaccharide (LPS), and lipopolysaccharide-binding protein (LBP). Mucosal immune function was assessed using secretory immunoglobulin A (sIgA), while oxidative stress was evaluated by measuring salivary malondialdehyde (MDA). Gut-brain axis responses were assessed using salivary cortisol and serotonin.
The study aimed to determine whether PosBion® supplementation could improve clinical outcomes in IBS while modulating biomarkers associated with intestinal inflammation, barrier integrity, mucosal immunity, oxidative stress, and gut-brain axis function, thereby providing mechanistic evidence supporting the therapeutic potential of postbiotics in IBS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was a single-arm, prospective, open-label interventional study in which all enrolled subjects received PosBion® postbiotic supplementation for 12 weeks. Clinical assessments and salivary biomarker measurements were performed at baseline and at Weeks 4, 8, and 12 to evaluate changes over time within the same cohort.
| Arm | Type | Receives |
|---|---|---|
| PosBion® Postbiotic Supplementation | Experimental | Dietary Supplement: Postbiotic supplementationSubjects received PosBion® postbiotic supplementation for 12 weeks. Each sachet contained Lactobacillus plantarum RS5 (2,500 mg) and Lactobacillus plantarum RI11 (2,500 mg). Subjects were instructed to consume two sachets daily throughout the intervention period. Clinical assessments and saliva samples were collected at baseline and at Weeks 4, 8, and 12 to evaluate changes in IBS symptoms, quality of life, gastrointestinal health, inflammatory biomarkers, intestinal barrier function, mucosal immunity, oxidative stress, and gut-brain axis biomarkers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Experienced one or more symptoms consistent with irritable bowel syndrome (IBS), including:
- Stomach pain or abdominal cramps
- Bloating
- Excessive gas
- Diarrhoea
Key exclusion criteria (8 listed)
- History of chronic or serious medical conditions, including but not limited to diabetes mellitus, cardiovascular disease, chronic kidney disease, cancer, or chronic respiratory disease.
- Current use of supplements intended to improve gut health.
- Current use of antibiotics or antiviral medications.
- Current use of probiotic, prebiotic, or postbiotic supplements.
- Major surgery within the previous 6 months.
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 |
|---|---|---|
| Postbiotic supplementationAlso: PosBion®PosBion® is a dietary postbiotic supplement containing inactivated Lactobacillus plantarum RS5 (2,500 mg) and Lactobacillus plantarum RI11 (2,500 mg) per sachet. Subjects consumed two sachets orally once daily for 12 weeks. The intervention was evaluated for its effects on IBS symptoms, quality of life, gastrointestinal health, intestinal inflammation, intestinal barrier integrity, mucosal immunity, oxidative stress, and gut-brain axis biomarkers. | Dietary supplement | PosBion® Postbiotic Supplementation |
Primary outcome
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Score
Time frame: Baseline, Week 4, Week 8, and Week 12
IBS-related quality of life was assessed using the 34-item Irritable Bowel Syndrome Quality of Life questionnaire. Raw item scores were transformed to a total score ranging from 0 to 100. Higher scores indicate better IBS-related quality of life and a better outcome.
Change in Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) Score
Time frame: Baseline, Week 4, Week 8, and Week 12
Irritable bowel syndrome symptom severity was assessed using the 5-item Irritable Bowel Syndrome Symptom Severity Scale. The scale evaluates abdominal pain severity, abdominal pain frequency, abdominal distension, dissatisfaction with bowel habits, and interference with daily life. The total score ranges from 0 to 500, with higher scores indicating more severe IBS symptoms and a worse outcome.
14 secondary outcomes
Change in Gastrointestinal Health Visual Analogue Scale (GI Health VAS)
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Calprotectin Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Interleukin-1β (IL-1β) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Interleukin-6 (IL-6) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Interleukin-8 (IL-8) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Lactoferrin Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Myeloperoxidase (MPO) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Zonulin Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Lipopolysaccharide (LPS) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Lipopolysaccharide-Binding Protein (LBP) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Secretory Immunoglobulin A (sIgA) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Malondialdehyde (MDA) Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Cortisol Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Salivary Serotonin Concentration
Time frame: Baseline, Week 4, Week 8, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 35014601Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067.
- Background: PubMed 39275354Roth B, Nseir M, Jeppsson H, D'Amato M, Sundquist K, Ohlsson B. A Starch- and Sucrose-Reduced Diet Has Similar Efficiency as Low FODMAP in IBS-A Randomized Non-Inferiority Study. Nutrients. 2024 Sep 9;16(17):3039. doi: 10.3390/nu16173039.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published articles, including demographic characteristics, clinical outcome measures, questionnaire scores, and biomarker data, will be made available to qualified researchers upon reasonable request. Requests must be accompanied by a scientifically sound research proposal and will be subject to approval by the principal investigator and study sponsor to ensure participant confidentiality and compliance with applicable ethical and institutional requirements. Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.
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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. This study is not recruiting at the moment.
Chung Keat Tan, PhD principal investigator
UCSI University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postbiotic supplementation in people with IBS (Irritable Bowel Syndrome) and IBD (Inflammatory Bowel Disease), run by My Myracle Sdn.Bhd at 1 site in Malaysia.
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 11 inclusion and 8 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: finished, as of the sponsor's last update on 14 Jul 2026. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Score (time frame: Baseline, Week 4, Week 8, and Week 12). The study lists 2 primary outcomes in all. 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 NCT07699926, 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 14 Jul 2026.