Actively Recruiting
Randomized Double-Blind Placebo-Controlled Trial of Skal Pro (Lactobacillus Plantarum 299 and Galacto-oligosaccharides) for Improving Symptoms, Stool Consistency, Quality of Life, and Psychological Function in Irritable Bowel Syndrome
Led by EP Plus Group Sdn Bhd · Updated on 2026-05-12
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of Skal Pro powder in reducing symptoms, improving stool consistency, enhancing quality of life, and addressing psychological distress in people with irritable bowel syndrome (IBS). IBS is linked to disruptions in the gut-brain axis and changes in gut bacteria, but the best probiotic strains for treatment are not yet clear. The study focuses on the effects of Skal Pro, containing Lactobacillus plantarum 299v and galactooligosaccharides (GOS), specifically within the Malaysian population. Participants will be randomly assigned to receive either Skal Pro powder or a placebo powder that looks and tastes the same. The Skal Pro sachet contains 10 billion CFU of freeze-dried Lactobacillus plantarum 299v and GOS. Each participant will take one sachet daily during the study, which will last for 4 weeks. During the study, participants will track and report their IBS symptoms, stool consistency and frequency, abdominal bloating, quality of life, and psychological factors using questionnaires and daily diaries. These assessments will occur at the start, during Week 1, Week 2, and at the end of Week 4. The main outcome measured is the change in IBS symptom severity. The study includes safety monitoring and will evaluate changes in several secondary outcomes related to gastrointestinal and psychological health.
CONDITIONS
Brief Title
Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- IBS diagnosed using the Rome IV criteria
- Age above 18 years old
- Any gender
- Any subtype of IBS (diarrhea, constipation, or mixed)
You will not qualify if you...
- Presence of red flag symptoms such as weight loss, anemia, night symptoms, abdominal mass, or strong family history of cancer
- Antibiotic use 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
- Overt psychiatric illnesses including schizophrenia and manic disorders
- History of allergy to probiotics
- Probiotic use within the past one month
- Previous use of Skal Pro (LP299V) probiotic
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants take one sachet of either Skal Pro or placebo daily to evaluate the effect on IBS symptoms.
Visits at baseline, Week 1, Week 2, and Week 4
Trial Site Locations
Total: 1 location
1
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150
Actively Recruiting
Research Team
J
Jonathan Khor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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