Galactol® Enzyme Supplement for Post-Prandial Abdominal Bloating in Irritable Bowel Syndrome

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.

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