Trials / Recruiting
RecruitingNCT06271538
Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome
A Randomized Double-Blind Placebo-controlled Clinical Trial on the Efficacy of Skål Pro (Lactobacillus Plantarum 299 and Galacto-oligosaccharides) in Improving Severity of Symptoms, Stool Forms, Quality of Life and Psychological Dysfunction in Patients With Irritable Bowel Syndrome (IBS)
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- EP Plus Group Sdn Bhd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention.
Detailed description
Irritable bowel syndrome (IBS) is a condition linked to disturbances in the gut-brain axis and dysbiosis. Although probiotic modulation of dysbiosis appears promising for IBS treatment, identifying the specific beneficial strains remains uncertain. Furthermore, even with an effective probiotic strain, variations in efficacy among populations are observed due to environmental heterogeneity, particularly dietary influences. This study seeks to provide efficacy insights into Skal Pro powder 2g (containing Lactobacillus plantarum 299v 1x10\^10 colony forming unit (CFU) and GOS), shedding light on the unique mechanisms of LP299V within the Malaysian population through a randomized controlled trial (RCT).
Conditions
- Irritable Bowel Syndrome
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Intestinal Disease
- Digestive System Disease
- Pathologic Processes
- Colonic Disease
- Disease
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Skal Pro | One sachet Skal Pro per day containing Lactobacillus plantarum 299v 1x10\^10 CFU and GOS |
| OTHER | Placebo | One sachet per day identical in shape, size, colour, packaging and taste to the Skal Pro sachet |
Timeline
- Start date
- 2024-10-17
- Primary completion
- 2025-07-31
- Completion
- 2025-11-30
- First posted
- 2024-02-21
- Last updated
- 2024-11-08
Locations
1 site across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT06271538. Inclusion in this directory is not an endorsement.