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Recruiting Phase 4 NCT06271538

Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome

Trial Parameters

Condition Irritable Bowel Syndrome
Sponsor EP Plus Group Sdn Bhd
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-10-17
Completion 2025-07-31
Interventions
Skal ProPlacebo

Brief 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 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™)

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