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

NCT07465562 | Completed DMC

• 1 other identifier: 156_9gennaio2026_GALACTOL®
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Post-Prandial Abdominal Bloating Intensity

  Change in the intensity of post-prandial abdominal bloating measured using a 0-10 visual analogue scale (VAS), where 0 indicates no symptoms and 10 indicates the worst symptoms.

  Baseline (Day 0) to Day 14

Secondary Outcomes (6)

• Change in Intestinal Symptoms

  Baseline to Day 14

• Change in Stool Consistency

  Baseline to Day 14

• Change in Frequency of Bowel Movements

  Baseline to Day 14

• Episodes of Diarrhea

  Baseline to Day 14

• Global Gastrointestinal Well-Being

  Day 14

Study Arms (2)

Galactol® + High-FODMAP Exclusion Diet

EXPERIMENTAL

Participants receive Galactol® enzyme supplementation in addition to a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs). The supplement is administered as two tablets at lunch and two tablets at dinner daily for 14 days.

Dietary Supplement: Galactol®; Behavioral: High-FODMAP Exclusion Diet

High-FODMAP Exclusion Diet Alone

ACTIVE COMPARATOR

Participants follow a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) without receiving the enzyme supplement during the 14-day study period.

Behavioral: High-FODMAP Exclusion Diet

Interventions

Galactol® DIETARY_SUPPLEMENT

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.

Also known as: Digestive enzyme supplement

Galactol® + High-FODMAP Exclusion Diet

High-FODMAP Exclusion Diet BEHAVIORAL

Participants follow a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) during the 14-day study period.

Galactol® + High-FODMAP Exclusion Diet; High-FODMAP Exclusion Diet Alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• University of Urbino "Carlo Bo": collaborator

Study Sites (1)

University of Urbino Carlo Bo

Urbino, 61029, Italy

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: (1) Galactol® enzyme supplementation plus a diet excluding foods high in FODMAPs, or (2) a diet excluding foods high in FODMAPs alone. The treatment duration is 14 days.

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: March 16, 2026
• Primary Completion: June 3, 2026
• Study Completion: June 3, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

IT (1)