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

NCT06271538 | Recruiting Phase 4

• 1 other identifier: EP-USM-122023-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  Assessed daily from baseline to Week 4.

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

  Assessed daily from baseline to Week 4.

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

  Assessed at baseline, Week 1, Week 2, and Week 4.

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

  Assessed at baseline, Week 1, Week 2, and Week 4.

• Change in Visceral Sensitivity Index

  Assessed at baseline, Week 1, Week 2, and Week 4.

Study Arms (2)

Skal Pro

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Skal Pro COMBINATION_PRODUCT

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

Skal Pro

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IBS diagnosed using the Rome IV criteria
• Age above 18 years old and any gender
• Any subtypes of IBS (diarrhea, constipation or mixed)

You may not qualify if:

• 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™)

Sponsors & Collaborators

• EP Plus Group Sdn Bhd: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Yeong Yeh Lee, MD, PhD

  Hospital Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Khor

CONTACT

+60122888024; jonathankhor@epplusgroup.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: October 17, 2024
• Primary Completion: July 31, 2025
• Study Completion: November 30, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)