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Completed
NCT06271538
Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome
Conditions: Irritable Bowel Syndrome, Gastrointestinal Diseases, Colonic Diseases, Functional, Intestinal Disease, Digestive System Disease, Pathologic Processes, Colonic Disease, Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 57
Sponsor: EP Plus Group Sdn Bhd
Location: Hospital Universiti Sains Malaysia Kubang Kerian Kelantan
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™)
Source: ClinicalTrials.gov (NCT06271538). StuddyBuddy aggregates publicly available trial information.
