Completed

FOGA Randomised Controlled Trial of the Effect of the Low FODMAP Diet and Dietary Oligofructose on Gastrointestinal Form, Function and Microbiota in Healthy Volunteers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

low FODMAP diet

+ Maltodextrin

+ Oligofructose

BehavioralDietary Supplement
Who is being recruted

Colonic Diseases+3

+ Colonic Diseases, Functional

+ Digestive System Diseases

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-Controlled
Interventional
Study Start: September 2014
See protocol details

Summary

Principal SponsorUniversity of Nottingham
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2014

Actual date on which the first participant was enrolled.

Oligofructose (OF) is a fructose- based oligosaccharide and defined in the European Union as a dietary fibre. Enzymatically derived from the longer chain inulin in chicory, it is commonly used in processed food to improve mouth feel in fat-free products. OF is poorly digested and absorbed in the small bowel so passes to the colon where it is fermented by the bacteria usually resident in the colon, termed the microbiota. This process produces gases such as hydrogen and sometimes methane, and short-chain fatty acids (SCFAs) which have a variety of roles including nutrition to colonocytes, immunological effects and modulation of intestinal motility. Its presence in the colon alters the composition of the microbiota, with reported potential benefits to health, leading to its description as a 'prebiotic'. Recently, however, such poorly digested carbohydrates grouped together by the term FODMAP (fermentable oligo-, di-, mono-saccharides and polyols) have been proposed to exacerbate symptoms of irritable bowel syndrome (IBS) such as abdominal discomfort and bloating. Dietary exclusion of foods containing FODMAPs, such as wheat, dairy and certain fruit and vegetables, has been proposed as a treatment for IBS, with some evidence to support this. FODMAPs are thought to induce symptoms either by drawing water into the small bowel by osmosis, or through gaseous distension of the large bowel or a combination of these along with metabolite effects on motility. The Nottingham GI MRI group has been at the forefront of elucidating the actual effects of FODMAPs on gastrointestinal (GI) physiology. We have published techniques to measure small bowel water content, colonic volume and gas volume and whole gut transit time. We have recently demonstrated that a single, large (40g) dose of inulin leads to an increase in colonic volume, mainly through an increase in colonic gas. Such a dose is beyond the usual range of dietary variation, however. Last year we piloted a model more similar to dietary practice. Participants supplemented their usual diet with 5g OF twice daily for a week. The most striking result was an 18% increase in fasting colonic volume. This could not be explained by changes in colonic gas and may represent proliferation, and increased mass, of the microbiota. That study was an open label, uncontrolled case series so we now wish to test the hypothesis in a double-blind, randomised controlled trial. For explanatory purposes we will also measure whole gut transit, colonic gas volume and hydrogen and methane expired in the breath. For exploratory purposes we will also collect stool and urine samples to allow assessment of the effect on microbiota and their metabolic output.

Official TitleA Randomised Controlled Trial of the Effect of the Low FODMAP Diet and Dietary Oligofructose on Gastrointestinal Form, Function and Microbiota in Healthy Volunteers
NCT02259465
Principal SponsorUniversity of Nottingham
Last updated: January 27, 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

45 patients to be enrolled

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

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



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.

Over 18 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.

Conditions

Pathology

Colonic DiseasesColonic Diseases, FunctionalDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesIrritable Bowel Syndrome

Criteria

2 inclusion criteria required to participate
Aged 18 or older

Able to give informed consent

16 exclusion criteria prevent from participating
Self-declared vegetarian, vegan or kosher/ halal diet who cannot eat carmine red dye

Pregnancy declared by candidate

History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function

A positive diagnosis of irritable bowel syndrome based on the Rome III criteria questionnaire

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

Placebo
Participants will be asked to follow the low FODMAP diet for a week, supplementing the diet with maltodextrin, 7grams twice daily

Group II

Active Comparator
Participants will be asked to follow the low FODMAP diet for a week, supplementing the diet with oligofructose, 7grams twice daily

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

Nottingham Digestive Diseases Centre

Nottingham, United KingdomOpen Nottingham Digestive Diseases Centre in Google Maps
CompletedOne Study Center