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Recruiting NCT06271538

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

Phase IV Interventional Irritable Bowel Syndrome Gastrointestinal Diseases Colonic Diseases, Functional Intestinal Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Skal Pro, Placebo.
Who it may be relevant to
Registry conditions: Irritable Bowel Syndrome, Gastrointestinal Diseases, Colonic Diseases, Functional, Intestinal Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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).

Interventions

  • Combination product Skal Pro
    One sachet Skal Pro per day containing Lactobacillus plantarum 299v 1x10\^10 CFU and GOS
  • Other Placebo
    One sachet per day identical in shape, size, colour, packaging and taste to the Skal Pro sachet

Primary outcome measures

  • 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.]
Secondary outcome measures (6)
  • Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary [Time frame: Assessed daily from baseline to Week 4.]
  • Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary [Time frame: Assessed daily from baseline to Week 4.]
  • Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ) [Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.]
  • Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire [Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.]
  • Change in Visceral Sensitivity Index [Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.]
  • Assessment of psychological dysfunction suing Catastrophizing Questionnaire [Time frame: 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™)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Malaysia · 1 center
  • Hospital Universiti Sains Malaysia — Kubang Kerian

Identifiers

NCT: NCT06271538 · EP-USM-122023-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗