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Galactol Supplementation and Low-FODMAP Diet for IBS Symptoms

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Study Aim

This study aims to evaluate the effect of Galactol supplementation and a Low-FODMAP diet on reducing the intensity of abdominal bloating after meals in individuals with Irritable Bowel Syndrome (IBS).

What is being tested

Galactol®

+ High-FODMAP Exclusion Diet

Dietary SupplementBehavioral
Who is being recruted

Colonic Diseases+3

+ Colonic Diseases, Functional

+ Digestive System Diseases

From 18 to 75 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorLiaquat University of Medical & Health Sciences
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 16, 2026

Actual date on which the first participant was enrolled.

This study focuses on Irritable Bowel Syndrome (IBS), a common disorder that often causes abdominal bloating and other intestinal symptoms after eating. Certain foods, especially those high in specific types of carbohydrates and gluten-related peptides, can worsen these symptoms. While dietary restrictions are commonly used to manage IBS, they can be challenging to maintain. This study explores an alternative approach: using a dietary supplement called Galactol®, which contains enzymes that help break down these problematic foods, potentially reducing intestinal discomfort. Adults diagnosed with IBS and experiencing food-related abdominal bloating are invited to participate. The study's goal is to determine if enzyme supplementation can improve food-related gastrointestinal symptoms in IBS patients. Participants will be randomly divided into two groups. One group will receive Galactol® supplementation along with a diet that excludes foods high in specific carbohydrates and gluten-related peptides, while the other group will follow the diet alone. The treatment period will last for 14 days. At the beginning and end of the treatment, assessments will be conducted to evaluate the intensity of abdominal bloating, additional gastrointestinal symptoms, stool consistency, frequency of bowel movements, episodes of diarrhea, overall gastrointestinal well-being, and treatment safety and tolerability. The primary outcome of the study is the change in post-meal abdominal bloating intensity, measured on a scale from 0 (no symptoms) to 10 (worst symptoms).

Official TitleEfficacy of a Mix of Specific Enzymes and Peptidases in Reducing Food-Related Abdominal Bloating: A Multicenter, Randomized, Controlled Clinical Trial
Principal SponsorLiaquat University of Medical & Health Sciences
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesColonic Diseases, FunctionalDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesIrritable Bowel Syndrome

Criteria

4 inclusion criteria required to participate
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

7 exclusion criteria prevent from participating
Pregnancy or breastfeeding

Antibiotic therapy within 30 days prior to enrollment

Age under 18 years

Presence of organic gastrointestinal diseases

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this group take Galactol® tablets twice daily and follow a diet avoiding foods high in certain carbohydrates and sugar alcohols, known as FODMAPs, for 14 days.

Group II

Active Comparator
Participants in this group follow a special diet that avoids foods high in certain types of carbohydrates, known as FODMAPs, for a period of 14 days. They do not receive any additional enzyme supplement.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Urbino Carlo Bo

Urbino, ItalyOpen University of Urbino Carlo Bo in Google Maps
Recruiting soonOne Study Center