NCT07465562

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

Efficacy of a Mix of Specific Enzymes and Peptidases in Reducing Food-Related Abdominal Bloating: A Multicenter, Randomized, Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Liaquat University of Medical & Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder frequently associated with post-prandial abdominal bloating and other intestinal symptoms. Certain dietary components, particularly foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs), can contribute to symptom development through increased intestinal fermentation and gas production. Dietary strategies such as restriction of high-FODMAP foods are commonly used to manage IBS-related symptoms. However, maintaining strict dietary restrictions can be difficult in routine clinical practice. Enzyme supplementation that facilitates the digestion of specific carbohydrates and gluten-related peptides may represent an alternative or complementary strategy to reduce intestinal fermentation and associated symptoms. Galactol® is a dietary supplement containing alpha-galactosidase, beta-galactosidase, and a prolyl-endopeptidase derived from Aspergillus niger. These enzymes are intended to promote the digestion of fermentable carbohydrates and gluten-related peptides that may contribute to gastrointestinal discomfort. This study is designed as a prospective, multicenter, randomized, controlled clinical trial with two parallel groups. Adult participants diagnosed with IBS according to Rome IV criteria and experiencing food-related abdominal bloating will be enrolled. Participants will be randomly assigned in a 1:1 ratio to receive either Galactol® supplementation in addition to a diet excluding foods high in FODMAPs, or the diet alone. The treatment period will last 14 days. Clinical assessments will be conducted at baseline and at the end of treatment. Outcomes will include evaluation of abdominal bloating intensity using a visual analogue scale (VAS), assessment of additional gastrointestinal symptoms, stool consistency using the Bristol Stool Scale, frequency of bowel movements, episodes of diarrhea, global gastrointestinal well-being, and treatment safety and tolerability. The study aims to determine whether enzyme supplementation may improve gastrointestinal symptoms related to food intake in patients with IBS.

Conditions

• Irritable Bowel Syndrome
• Abdominal Bloating

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
BEHAVIORAL	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.

Timeline

• Start date: 2026-03-16
• Primary completion: 2026-06-30
• Completion: 2026-07-31
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: Italy