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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Diseases; Pathologic Processes; Disease; Irritable Bowel Syndrome; Colonic Diseases, Functional; Digestive System Disease; Intestinal Disease; Colonic Disease
• Intervention / Treatment: Combination product: Skal Pro; Other: Placebo

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jonathan Khor; Phone Number: +60122888024; Email: jonathankhor@epplusgroup.com

Study Locations

• Malaysia
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • Hospital Universiti Sains Malaysia
      • Principal Investigator: Yeong Yeh Lee, MD, PhD
      • Contact: Yeong Yeh Lee, MD, PhD; Phone Number: 6845 +6097676846; Email: yylee@usm.my
      • Sub-Investigator: Thai Hau Koo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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™)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Combination product: Skal Pro; One sachet Skal Pro per day containing Lactobacillus plantarum 299v 1x10^10 CFU and GOS
Placebo Comparator: Placebo; Placebo is an oral formulation of inert powder. Placebo and Skal Pro are identical in shape, size, colour, packaging and taste.	Other: Placebo; One sachet per day identical in shape, size, colour, packaging and taste to the Skal Pro sachet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS)	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.	Assessed at baseline, Week 1, Week 2, and Week 4.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary	Daily diary of number of bowel movements.	Assessed daily from baseline to Week 4.
Change in Visceral Sensitivity Index	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.	Assessed at baseline, Week 1, Week 2, and Week 4.
Assessment of psychological dysfunction suing Catastrophizing Questionnaire	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.	Assessed at baseline, Week 1, Week 2, and Week 4.
Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary	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	Assessed daily from baseline to Week 4.
Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ)	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.	Assessed at baseline, Week 1, Week 2, and Week 4.
Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire	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.	Assessed at baseline, Week 1, Week 2, and Week 4.

Collaborators and Investigators

• Sponsor: EP Plus Group Sdn Bhd
• Investigators: Principal Investigator: Yeong Yeh Lee, MD, PhD, Hospital Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: probiotic; Lactobacillus plantarum 299v; randomized controlled study
• Additional Relevant MeSH Terms: Disease; Syndrome; Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Colonic Diseases; Colonic Diseases, Functional
• Other Study ID Numbers: EP-USM-122023-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes