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

NCT07465562 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome
  • Abdominal Bloating

Interventions

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.

Sponsors & Collaborators

  • University of Urbino "Carlo Bo"

    collaborator OTHER

  • Liaquat University of Medical & Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2026-06-30
Completion
2026-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07465562 on ClinicalTrials.gov