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Completed

NCT Number: NCT06271538

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

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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Key information

Conditions

Irritable Bowel Syndrome Colonic Disease Colonic Diseases Colonic Diseases, Functional Digestive System Disease Digestive System Diseases Disease Gastrointestinal Diseases Intestinal Disease Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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™)

Treatment and study plan

Skal Pro

Combination Product

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

Placebo

Other

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

Primary outcomes

  1. 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

  1. Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary

    Time frame: Assessed daily from baseline to Week 4.

    Daily diary of stool consistency of each bowel movement based on Bristol Stool Scale (Type 1-7), from type 1-2 = separate hard lump stool, type 3-4= ideal stool, type 5-7 =loose stool

  2. Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary

    Time frame: Assessed daily from baseline to Week 4.

    Daily diary of number of bowel movements.

  3. Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ)

    Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.

    Originally developed by Thiwan et al., this research group then translated and validated the BSQ in the Malay language (BSQ-M) [13]. There are 2 sub-scales, the 6-item Sev-Gen (Severity-General) and 5-item Sev-24 (Severity-24 hour) with responses in seven-point Likert scale on different degree of severity (from 1 = never to 7=always). For this study, only the Sev-Gen will be used.

  4. Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire

    Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.

    The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009, and consist of 2 sections, 1) the EQ-5D descriptive system and 2) the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain or discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health the participant can imagine' and 'The worst health the participant can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. The Malay version questionnaire will be used.

  5. Change in Visceral Sensitivity Index

    Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.

    The Visceral Sensitivity Index (VSI) is a 15-item questionnaire which measures gastrointestinal symptom-specific anxiety. Replies to each item are provided on a 6-point scale from "strongly disagree" (scored as 0) to "strongly agree" (scored as 5). A Malay version of the questionnaire was developed using standard forward-back translation procedures. The Malay version questionnaire will be used.

  6. Assessment of psychological dysfunction suing Catastrophizing Questionnaire

    Time frame: Assessed at baseline, Week 1, Week 2, and Week 4.

    The Coping Strategies Questionnaire (CSQ) - Catastrophizing (CAT) subscale consists of six questions on a 6-point Likert scale, with response options ranging from 0 (never) to 5 (very frequently). The Malay version questionnaire will be used.

Sponsors and collaborators

Lead sponsor

EP Plus Group Sdn Bhd

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2024
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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