Galactol® Enzyme Supplement for Post-Prandial Abdominal Bloating in Irritable Bowel Syndrome (NCT07465562) | Clinical Trial Compass
CompletedNot Applicable
Galactol® Enzyme Supplement for Post-Prandial Abdominal Bloating in Irritable Bowel Syndrome
Italy300 participantsStarted 2026-03-16
Plain-language summary
This multicenter, randomized, controlled clinical trial aims to evaluate the efficacy and safety of a dietary supplement containing a combination of digestive enzymes (alpha-galactosidase, beta-galactosidase, and prolyl-endopeptidase) in reducing post-prandial abdominal bloating in adults diagnosed with irritable bowel syndrome (IBS).
Participants will be randomly assigned in a 1:1 ratio to receive either the enzyme supplement (Galactol®) in addition to a diet excluding foods high in FODMAPs, or the diet alone. The intervention will be administered for 14 days.
The primary objective is to assess the change in the intensity of post-prandial abdominal bloating measured using a visual analogue scale (VAS). Secondary outcomes include changes in intestinal symptoms, stool consistency, bowel movement frequency, episodes of diarrhea, global gastrointestinal well-being, and treatment tolerability.
The results of this study will provide evidence regarding the potential role of enzyme supplementation in reducing gastrointestinal symptoms associated with food-related fermentation in patients with IBS.
Who can participate
Age range
18 Years – 75 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:
* Adults aged 18 years or older
* Diagnosis of irritable bowel syndrome (IBS) according to Rome IV criteria
* Presence of abdominal discomfort and bloating related to food ingestion
* Ability and willingness to provide written informed consent
Exclusion Criteria:
* Age under 18 years
* Antibiotic therapy within 30 days prior to enrollment
* Presence of organic gastrointestinal diseases
* History of digestive system resection
* Pregnancy or breastfeeding
* Drug use or alcohol abuse during the study period
* Inability or refusal to provide written informed consent
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
Change in Post-Prandial Abdominal Bloating Intensity
Timeframe: Baseline (Day 0) to Day 14
Trial details
NCT IDNCT07465562
SponsorLiaquat University of Medical & Health Sciences