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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-17

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Irritable Bowel Syndrome Gastrointestinal Diseases Colonic Diseases, Functional Intestinal Disease Digestive System Disease Pathologic Processes Colonic Disease Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Skal Pro

Skal Pro in the form of 2g sachet powder contains 10 billion CFU of freeze-dried Lactobacillus plantarum 299v (LP299V) and galactooligosaccharides (GOS).

Group Type EXPERIMENTAL

Skal Pro

Intervention Type COMBINATION_PRODUCT

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

Placebo

Placebo is an oral formulation of inert powder. Placebo and Skal Pro are identical in shape, size, colour, packaging and taste.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Skal Pro

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

Intervention Type COMBINATION_PRODUCT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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™)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No