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)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- EP Plus Group Sdn Bhd
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Detailed Description
Irritable bowel syndrome (IBS) is a condition linked to disturbances in the gut-brain axis and dysbiosis. Although probiotic modulation of dysbiosis appears promising for IBS treatment, identifying the specific beneficial strains remains uncertain. Furthermore, even with an effective probiotic strain, variations in efficacy among populations are observed due to environmental heterogeneity, particularly dietary influences. This study seeks to provide efficacy insights into Skal Pro powder 2g (containing Lactobacillus plantarum 299v 1x10\^10 colony forming unit (CFU) and GOS), shedding light on the unique mechanisms of LP299V within the Malaysian population through a randomized controlled trial (RCT).
Investigators
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™)
Outcomes
Primary Outcomes
Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS)
Time Frame: Assessed at baseline, Week 1, Week 2, and Week 4.
IBSSS questionnaire contains five questions that measures, on a 100-point visual analogue scale (VAS), the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and interference with quality of life (QOL). All five components contribute to the scores equally, yielding a theoretically range of 0 - 500, with a higher score indicating worse condition. The Malay version questionnaire will be used.
Secondary Outcomes
- Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ)(Assessed at baseline, Week 1, Week 2, and Week 4.)
- Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary(Assessed daily from baseline to Week 4.)
- Change in Visceral Sensitivity Index(Assessed at baseline, Week 1, Week 2, and Week 4.)
- Assessment of psychological dysfunction suing Catastrophizing Questionnaire(Assessed at baseline, Week 1, Week 2, and Week 4.)
- Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary(Assessed daily from baseline to Week 4.)
- Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire(Assessed at baseline, Week 1, Week 2, and Week 4.)