Galactol Supplementation and Low-FODMAP Diet for IBS Symptoms
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).
Galactol®
+ High-FODMAP Exclusion Diet
Colonic Diseases+3
+ Colonic Diseases, Functional
+ Digestive System Diseases
Treatment Study
Summary
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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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