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The effect of a low fementable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) diet on intestinal transit, the intestinal microbiome and metabolome in adults with irritable bowel syndrome..

An intervention study investigating the effect of a low fermentable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) diet on gastrointestinal transit time and diversity of the microbiome and metabolome in adults with irritable bowel syndrome.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000465358
Enrollment
5
Registered
2017-03-30
Start date
2017-08-09
Completion date
2017-09-13
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The low FODMAP diet has been shown to be effective for ~70% of IBS patients. However, concerns have been raised that as it is lower in oligosaccharides it may reduce the variety of bacteria in the bowel (microbial diversity). Microbial diversity is associated with health. Two recently published studies have suggested that for people with IBS(D) following a low FODMAP diet may not have a reduction in microbial diversity. One other factor associated with increased diversity is longer transit time through the gastrointestinal tract. We are using a wireless motility capsule or a “smartpill” to measure intestinal transit time, pH, temperature and pressure when participants are following a normal diet and when they are following a low FODMAP diet. The purpose of this study is to see if a low FODMAP diet slows down transit through the intestines and if it has an effect on pH inside the gastrointestinal tract. 10 people with IBS who enrolled for ACTRN12616001162404 but did not have SIBO will be asked to participate in this study.

Interventions

10 participants with diarrhea predominant irritable bowel syndrome [IBS(D)] or [IBS(M)] from study ACTRN12616001162404 who do not have small intestinal bacteria overgrowth will be asked to participate. They will be educated on a low FODMAP diet which is low in fermentable short chain carbohydrates. Foods which participants need to reduce include but are not limited to wheat products, apples, onion and garlic. They will be shown the Monash University low FODMAP app, which includes a traffic ligh

10 participants with diarrhea predominant irritable bowel syndrome [IBS(D)] or [IBS(M)] from study ACTRN12616001162404 who do not have small intestinal bacteria overgrowth will be asked to participate. They will be educated on a low FODMAP diet which is low in fermentable short chain carbohydrates. Foods which participants need to reduce include but are not limited to wheat products, apples, onion and garlic. They will be shown the Monash University low FODMAP app, which includes a traffic light system on which foods are suitable and a video clip on how the diet works as well as recipes. They will be given additional recipes to use that are low FODMAP. They will be asked to follow this diet strictly. Dietary education will be given by a New Zealand registered dietitian with 10 years experience who is familiar with a low FODMAP diet. These education session with be conducted individually and last for 45 minutes. Timeline for the diet and investigations: Week 1: participants follow usual diet Week 2: participants provide a second urine and stool sample (the first fecal and urine samples were given in the earlier trial ACTRN12616001162404) after which they consume a smart pill while on their usual diet Week 3-6: participants follow a strict low FODMAP diet (receiving 45 minutes dietary education at the beginning of week 3) Week 7: participants provide a third urine and stool sample after which they consume a smart pill. During this week they remain on a strict low FODMAP diet Week 8-12: Participants will be given 30 minutes education on how to reintroduce FODMAP containing foods to tolerance Adherence to the diet will be measured by 7 telephone diet recalls conducted by two nutrition students (done in weeks 1-7). They will be checking for evidence of high FODMAP food intake and reporting on this. Each participant will act as their own control therefore 10 participants should be sufficient for this part of the study.

Sponsors

Michael Schultz
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

*Previously enrolled in study ACTRN12616001162404 *IBS (D) or IBS (M) according to Rome III criteria *Fluent in English

Exclusion criteria

* Organic gastrointestinal disease * Diabetes * Serious neurological or respiratory conditions * Pancreatitis * Small intestinal bacteria overgrowth * Antibiotics within the last six week

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026