Completed

Effect of Galacto-oligosaccharides on Intestinal Microbiota Composition and Activity in Healthy Adults

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Study Aim

This study aims to investigate how Galacto-oligosaccharides affect the composition and activity of intestinal microbiota in healthy adults, using advanced techniques like metatranscriptomics and 16S rRNA gene sequencing.

What is being tested

Galacto-oligosaccharides

+ Maltodextrin

Dietary Supplement
Who is being recruted

From 18 to 50 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: September 2019
See protocol details

Summary

Principal SponsorMaastricht University Medical Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 17, 2019

Actual date on which the first participant was enrolled.

This study focuses on understanding the impact of galacto-oligosaccharides (GOS), a type of dietary fiber, on the health of the intestinal microbiota, or the community of microorganisms living in the gut. The study aims to explore how GOS affects the microbiota in the proximal colon, the primary site of carbohydrate fermentation, in healthy adults. The importance of this study lies in gaining a deeper understanding of how GOS may improve intestinal health, which could lead to targeted approaches for enhancing overall well-being. During this randomized, double-blind, placebo-controlled trial, healthy participants between the ages of 18 and 50 will receive either GOS supplementation (Vivinal® GOS Powder) or a placebo (maltodextrin) three times daily for four weeks. The study measures the changes in microbial composition and activity in the colon after GOS intervention. This is done by analyzing colonic luminal samples and biopsies using advanced techniques such as metatranscriptomics and HiSeq sequencing. Additionally, the study monitors the effects of GOS supplementation on gastrointestinal symptoms. The results will provide valuable insights into how GOS impacts the intestinal microbiota and may pave the way for better strategies to support gut health.

Official TitleImpact of Galacto-oligosaccharides on the Intestinal Microbial Composition and -Activity: a Proof of Concept Study
NCT04104360
Principal SponsorMaastricht University Medical Center
Last updated: January 28, 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

8 patients to be enrolled

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

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

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

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

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

Criteria

5 inclusion criteria required to participate
Based on medical history no gastrointestinal complaints can be defined
Regular stool frequency ranging from 3 times/day - 3 times/week
Body Mass Index (BMI) >= 20 and < 30 kg/m2
Weight-stable for at least 90 days prior to participation (no change in bodyweight, i.e. < 3kg)
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20 exclusion criteria prevent from participating
Plan to lose weight or follow a specific diet within the study period
Pregnancy or lactation
Alcohol intake > 14 units/week
Use of laxatives within 14 days prior to the study
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

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants in this group will take Vivinal GOS supplements, 7.2 grams three times a day, for a duration of four weeks.

Group II

Placebo
Participants in this group will take maltodextrin supplements, which look like the real treatment but contain no active ingredients, three times a day for four weeks.

Study Objectives

Primary 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

Maastricht University Medical Center

Maastricht, NetherlandsOpen Maastricht University Medical Center in Google Maps
CompletedOne Study Center