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

March 6, 2026 updated by: Liaquat University of Medical & Health Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Galactol® + High-FODMAP Exclusion Diet
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®
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.
Other Names:
  • Digestive enzyme supplement
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.
Active Comparator: High-FODMAP Exclusion Diet Alone
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
Participants follow a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) during the 14-day study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Post-Prandial Abdominal Bloating Intensity
Time Frame: Baseline (Day 0) to Day 14
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intestinal Symptoms
Time Frame: Baseline to Day 14
Change in the intensity of intestinal symptoms including flatulence, abdominal discomfort, abdominal pain, and bowel urgency assessed using a 0-10 visual analogue scale (VAS).
Baseline to Day 14
Change in Stool Consistency
Time Frame: Baseline to Day 14
Stool consistency assessed using the Bristol Stool Scale (types 1-7).
Baseline to Day 14
Change in Frequency of Bowel Movements
Time Frame: Baseline to Day 14
Average number of bowel movements per day during the evaluation period.
Baseline to Day 14
Episodes of Diarrhea
Time Frame: Baseline to Day 14
Number of diarrhea episodes per day recorded during the study period.
Baseline to Day 14
Global Gastrointestinal Well-Being
Time Frame: Day 14
Participant-reported perception of gastrointestinal well-being using the Global GI Well-Being Scale (improved, unchanged, or worsened symptoms).
Day 14
Treatment Adherence and Tolerability
Time Frame: Day 14
Treatment adherence assessed as percentage of prescribed tablets taken and tolerability evaluated using a 0-10 scale at the end of treatment.
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaquat University of Medical & Health Sciences

Collaborators

University of Urbino "Carlo Bo"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 16, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156_9gennaio2026_GALACTOL®

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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