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Galactol® Enzyme Supplement for Post-Prandial Abdominal Bloating in Irritable Bowel Syndrome
Sponsor: Liaquat University of Medical & Health Sciences
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.
Official title: Efficacy of a Mix of Specific Enzymes and Peptidases in Reducing Food-Related Abdominal Bloating: A Multicenter, Randomized, Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-03-16
Completion Date
2026-07-31
Last Updated
2026-03-12
Healthy Volunteers
No
Interventions
Galactol®
Galactol® is a dietary supplement containing alpha-galactosidase, beta-galactosidase, and prolyl-endopeptidase derived from Aspergillus niger. The supplement is administered orally as two tablets at lunch and two tablets at dinner daily for 14 days.
High-FODMAP Exclusion Diet
Participants follow a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) during the 14-day study period.
Locations (1)
University of Urbino Carlo Bo
Urbino, Italy