UCSI University
Cheras, Kuala Lumpur, 56000, Malaysia
NCT Number: NCT07699926
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cheras, Kuala Lumpur, 56000, Malaysia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: PosBion®
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.
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.
Time frame: Baseline, Week 4, Week 8, and Week 12
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.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary calprotectin concentration was measured using enzyme-linked immunosorbent assay (ELISA) as a marker of intestinal inflammation and neutrophil activation.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary IL-1β concentration was measured using ELISA as a marker of pro-inflammatory cytokine activity.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary IL-6 concentration was measured using ELISA as a marker of inflammatory responses.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary IL-8 concentration was measured using ELISA as a marker of neutrophil recruitment and intestinal inflammatory responses.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary lactoferrin concentration was measured using ELISA as a marker of neutrophil activation and intestinal inflammation.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary myeloperoxidase concentration was measured using ELISA as a marker of neutrophil-derived oxidative inflammatory activity.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary zonulin concentration was measured using ELISA as a marker of intestinal barrier integrity and intestinal permeability.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary lipopolysaccharide concentration was measured using ELISA to evaluate microbial endotoxin exposure associated with intestinal permeability.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary lipopolysaccharide-binding protein concentration was measured using ELISA as an indicator of host response to bacterial endotoxin and microbial translocation.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary secretory immunoglobulin A concentration was measured using ELISA to assess mucosal immune function.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary malondialdehyde concentration was measured using ELISA as a marker of lipid peroxidation and oxidative stress.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary cortisol concentration was measured using ELISA to assess physiological stress responses associated with the gut-brain axis.
Time frame: Baseline, Week 4, Week 8, and Week 12
Salivary serotonin concentration was measured using ELISA as a biomarker of gut-brain axis function and neurotransmitter regulation.
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