Clinical trial NCT06271538: Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Gastrointestinal Diseases
Colonic Diseases, Functional
Intestinal Disease
Digestive System Disease
Pathologic Processes
Colonic Disease
Disease
Keywords: probiotic
Lactobacillus plantarum 299v
randomized controlled study
Lead sponsor: EP Plus Group Sdn Bhd
Sponsor class: INDUSTRY
First posted: 2024-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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™)

Primary outcomes:
measure: Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS)
timeFrame: Assessed at baseline, Week 1, Week 2, and Week 4.
Secondary outcomes:
measure: Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary
timeFrame: Assessed daily from baseline to Week 4.
measure: Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary
timeFrame: Assessed daily from baseline to Week 4.
measure: Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ)
timeFrame: Assessed at baseline, Week 1, Week 2, and Week 4.
measure: Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire
timeFrame: Assessed at baseline, Week 1, Week 2, and Week 4.
measure: Change in Visceral Sensitivity Index
timeFrame: Assessed at baseline, Week 1, Week 2, and Week 4.
measure: Assessment of psychological dysfunction suing Catastrophizing Questionnaire
timeFrame: Assessed at baseline, Week 1, Week 2, and Week 4.
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
Study officials:
affiliation: Hospital Universiti Sains Malaysia
name: Yeong Yeh Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: