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

EP Plus Group Sdn Bhd

Status and phase: Enrolling; Phase 4

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

Treatments: Other: Placebo; Combination Product: Skal Pro

Study type: Interventional

Funder types: Industry

Identifiers

NCT06271538

EP-USM-122023-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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™)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups, including a placebo group

Skal Pro

Experimental group

Description:

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

Treatment:

Combination Product: Skal Pro

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo