Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome (NCT06271538) | Clinical Trial Compass
RecruitingPhase 4
Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome
Malaysia60 participantsStarted 2024-10-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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™)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS)
Timeframe: Assessed at baseline, Week 1, Week 2, and Week 4.