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The role of dietary Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols (FODMAPs) in the genesis of symptoms in patients with irritable bowel syndrome and Crohn's disease

The role of dietary Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols (FODMAPs) in the genesis of symptoms in patients with irritable bowel syndrome and Crohn's disease

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001185853
Enrollment
78
Registered
2012-11-09
Start date
2008-04-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

FODMAPs are poorly absorbed sugars that putatively contribute to gastrointestinal symptoms in irritable bowel syndrome (IBS). Supporting evidence comprises confirmation of mechanisms of action, effects of acute challenge with individual FODMAPs/foods, observational studies in IBS and quiescent Crohn’s disease, randomised controlled trials of fructose and fructan rechallenges in IBS patients with controlled symptoms on a low FODMAP diet and a non-randomised comparative study. We aim to fill evidence gaps regarding effects on symptoms over the longer term with the low FODMAP diet compared to the moderate FODMAP intake on a typical Australian diet by comparing GI symptoms in unselected IBS patients consuming such diets with those in healthy and disease controls (quiescent Crohn's disease).

Interventions

Dietary intervention of a low FODMAP (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols) diet. The low FODMAP diet is a diet with very low amounts of these fermentable sugars and requires the restriction of foods such as milk, apples, pears, watermelon, wheat, rye, onion and garlic. Participants were provided with low FODMAP meals (3 meals and 3 snacks daily) but asked to control the meal/snack portions according to their appetite. The average daily FODMAP content on th

Dietary intervention of a low FODMAP (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols) diet. The low FODMAP diet is a diet with very low amounts of these fermentable sugars and requires the restriction of foods such as milk, apples, pears, watermelon, wheat, rye, onion and garlic. Participants were provided with low FODMAP meals (3 meals and 3 snacks daily) but asked to control the meal/snack portions according to their appetite. The average daily FODMAP content on the low FODMAP diet was less than 2g compared to the average typical Australian diet of 20g. Participants are required to follow a low FODMAP and typical Australian diet for three weeks each and all food is provided. This trial is a crossover study which was already provided in a later field of this trial record. All food will be provided on three weeks of the low FODMAP and three weeks of the typical Australian diet. All participants will have a minimum of three-week washout period (returning to their usual diet) before crossing over to the alternate diet

Sponsors

National Health and Medical Research Council
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

IBS: FODMAP-naive, IBS diagnosed by Rome III criteria Crohn's disease: inactive disease Healthy controls: no reported gastrointestinal symptoms

Exclusion criteria

Crohn's disease: prior bowel resection

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 22, 2026