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)
EP Plus Group Sdn Bhd
60 participants
Oct 17, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- IBS diagnosed using the Rome IV criteria
- Age above 18 years old and any gender
- Any subtypes of IBS (diarrhea, constipation or mixed)
Exclusion Criteria10
- Presence of red flag symptoms (weight loss, anemia, night symptoms, abdominal mass, strong family history of cancer)
- Was prescribed antibiotic (s) within the past one month
- Medical conditions that contraindicate probiotic use including severe sepsis and pregnancy
- Presence of bowel malignancy
- Diagnosis of bowel infection within the past one month
- Previous abdominal surgeries
- Patients with overt psychiatric illnesses including schizophrenia and manic disorders
- A history of allergy to probiotic
- Was prescribed probiotic (s) within the past one month
- Was previously prescribed probiotic Skal Pro™ (LP299V™)
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Interventions
One sachet Skal Pro per day containing Lactobacillus plantarum 299v 1x10\^10 CFU and GOS
One sachet per day identical in shape, size, colour, packaging and taste to the Skal Pro sachet
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06271538