Evaluating Skål Pro Powder for Irritable Bowel Syndrome Symptoms
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)
PHASE4 · EP Plus Group Sdn Bhd · NCT06271538
This study is testing if Skål Pro powder, which has a specific probiotic, can help people with irritable bowel syndrome feel better and improve their quality of life.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EP Plus Group Sdn Bhd (industry) |
| Locations | 1 site (Kubang Kerian, Kelantan) |
| Trial ID | NCT06271538 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled study aims to assess the effectiveness of Skål Pro powder, which contains Lactobacillus plantarum 299v, in alleviating symptoms of irritable bowel syndrome (IBS). The study will compare the outcomes of participants receiving the probiotic treatment against those receiving a placebo. It focuses on improvements in stool consistency, quality of life, and psychological distress among individuals diagnosed with IBS, particularly within the Malaysian population. The research seeks to clarify the unique mechanisms of the probiotic strain in this demographic.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with any subtype of irritable bowel syndrome according to the Rome IV criteria.
Not a fit: Patients with severe underlying medical conditions, recent antibiotic use, or specific psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from irritable bowel syndrome.
How similar studies have performed: Previous studies have shown promise in using probiotics for IBS treatment, but the specific efficacy of Lactobacillus plantarum 299v remains to be fully established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * IBS diagnosed using the Rome IV criteria * Age above 18 years old and any gender * Any subtypes of IBS (diarrhea, constipation or mixed) Exclusion Criteria: * 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™)
Where this trial is running
Kubang Kerian, Kelantan
- Hospital Universiti Sains Malaysia — Kubang Kerian, Kelantan, Malaysia (RECRUITING)
Study contacts
- Principal investigator: Yeong Yeh Lee, MD, PhD — Hospital Universiti Sains Malaysia
- Study coordinator: Jonathan Khor
- Email: jonathankhor@epplusgroup.com
- Phone: +60122888024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Irritable Bowel Syndrome, Gastrointestinal Diseases, Colonic Diseases, Functional, Intestinal Disease, Digestive System Disease, Pathologic Processes, Colonic Disease, Disease