Gut Health, IBD (Inflammatory Bowel Disease), IBS (Irritable Bowel Syndrome)
Conditions
Keywords
Irritable Bowel Syndrome, Postbiotic, PosBion®, Lactobacillus plantarum, Gut Health, Functional Gastrointestinal Disorder
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTPostbiotic supplementation
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.
Sponsors
My Myracle Sdn.Bhd
UCSI University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Score | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastrointestinal Health Visual Analogue Scale (GI Health VAS) | 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. |
| Change in Salivary Calprotectin Concentration | 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. |
| Change in Salivary Interleukin-1β (IL-1β) Concentration | Baseline, Week 4, Week 8, and Week 12 | Salivary IL-1β concentration was measured using ELISA as a marker of pro-inflammatory cytokine activity. |
| Change in Salivary Interleukin-6 (IL-6) Concentration | Baseline, Week 4, Week 8, and Week 12 | Salivary IL-6 concentration was measured using ELISA as a marker of inflammatory responses. |
| Change in Salivary Interleukin-8 (IL-8) Concentration | 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. |
| Change in Salivary Lactoferrin Concentration | Baseline, Week 4, Week 8, and Week 12 | Salivary lactoferrin concentration was measured using ELISA as a marker of neutrophil activation and intestinal inflammation. |
| Change in Salivary Myeloperoxidase (MPO) Concentration | Baseline, Week 4, Week 8, and Week 12 | Salivary myeloperoxidase concentration was measured using ELISA as a marker of neutrophil-derived oxidative inflammatory activity. |
| Change in Salivary Zonulin Concentration | 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. |
| Change in Salivary Lipopolysaccharide (LPS) Concentration | Baseline, Week 4, Week 8, and Week 12 | Salivary lipopolysaccharide concentration was measured using ELISA to evaluate microbial endotoxin exposure associated with intestinal permeability. |
| Change in Salivary Lipopolysaccharide-Binding Protein (LBP) Concentration | 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. |
| Change in Salivary Secretory Immunoglobulin A (sIgA) Concentration | Baseline, Week 4, Week 8, and Week 12 | Salivary secretory immunoglobulin A concentration was measured using ELISA to assess mucosal immune function. |
| Change in Salivary Malondialdehyde (MDA) Concentration | Baseline, Week 4, Week 8, and Week 12 | Salivary malondialdehyde concentration was measured using ELISA as a marker of lipid peroxidation and oxidative stress. |
| Change in Salivary Cortisol Concentration | 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. |
| Change in Salivary Serotonin Concentration | 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. |
Countries
Malaysia
Contacts
PRINCIPAL_INVESTIGATORChung Keat Tan, PhD
UCSI University
Outcome results
None listed