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Completed
NCT07699926
Efficacy of PosBion® Postbiotic Supplementation in Adults With Irritable Bowel Syndrome
Conditions: IBS (Irritable Bowel Syndrome), IBD (Inflammatory Bowel Disease), Gut Health
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 55
Sponsor: My Myracle Sdn.Bhd
Location: UCSI University Cheras Kuala Lumpur
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. 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.
Eligibility Criteria
Inclusion Criteria:
* 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)
* 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.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07699926). StuddyBuddy aggregates publicly available trial information.