Clinical trial

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)

Name

EP-USM-122023-001

Description

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.

Trial arms

Trial start

2024-05-31

Estimated PCD

2024-11-30

Trial end

2025-03-30

Status

Not yet recruiting

Phase

Early phase I

Treatment

Skal Pro

One sachet Skal Pro per day containing Lactobacillus plantarum 299v 1x10\^10 CFU and GOS

Arms:

Skal Pro

Placebo

One sachet per day identical in shape, size, colour, packaging and taste to the Skal Pro sachet

Arms:

Placebo

Size

Primary endpoint

Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS)

Assessed at baseline, Week 1, Week 2, and Week 4.

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™)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-04-26

1 organization

1 product

9 indications

Organization

EP Plus Group

Product

Skal Pro

Indication

Irritable Bowel Syndrome

Indication