Efficacy of PosBion® Postbiotic Supplementation in Adults With Irritable Bowel Syndrome

NCT07699926 | Completed

• 1 other identifier: IEC-2025-FMHS-0017
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS (Irritable Bowel Syndrome); IBD (Inflammatory Bowel Disease); Gut Health

Keywords

Irritable Bowel Syndrome; Postbiotic; PosBion®; Lactobacillus plantarum; Gut Health; Functional Gastrointestinal Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes (14)

• Change in Gastrointestinal Health Visual Analogue Scale (GI Health VAS)

  Baseline, Week 4, Week 8, and Week 12

• Change in Salivary Calprotectin Concentration

  Baseline, Week 4, Week 8, and Week 12

• Change in Salivary Interleukin-1β (IL-1β) Concentration

  Baseline, Week 4, Week 8, and Week 12

• Change in Salivary Interleukin-6 (IL-6) Concentration

  Baseline, Week 4, Week 8, and Week 12

• Change in Salivary Interleukin-8 (IL-8) Concentration

  Baseline, Week 4, Week 8, and Week 12

Study Arms (1)

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.

Dietary Supplement: Postbiotic supplementation

Interventions

Postbiotic supplementation DIETARY_SUPPLEMENT

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.

Also known as: PosBion®

PosBion® Postbiotic Supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• My Myracle Sdn.Bhd: lead
• UCSI University: collaborator

Study Sites (1)

UCSI University

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (2)

• 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.

  PMID: 35014601 BACKGROUND

• Roth 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.

  PMID: 39275354 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Inflammatory Bowel Diseases; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Digestive System Diseases; Gastroenteritis

Study Officials

• Chung Keat Tan, PhD

  UCSI University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: January 1, 2026
• Primary Completion: May 31, 2026
• Study Completion: June 30, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Six months after publication of the primary study results and will remain available for 5 years.
• Access Criteria: Qualified researchers with a scientifically sound research proposal will be eligible. Access requests will be reviewed and approved by the principal investigator and study sponsor.

Locations

MY (1)