Evidence map›Paper›PMID 34617561›Full record

Trial reportThe American journal of clinical nutrition2022

Fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs), but not gluten, elicit modest symptoms of irritable bowel syndrome: a double-blind, placebo-controlled, randomized three-way crossover trial.

Elise Nordin, Carl Brunius, Rikard Landberg, Per M Hellström

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal of clinical nutrition, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03653689 (Molecular Phenotyping of IBS Subtypes), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
8.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03653689 nacompletednot on this map

Molecular Phenotyping of IBS Subtypes

TypeinterventionalSponsorUppsala UniversityRan2018 to 2019Enrolled110ConditionsIrritable Bowel SyndromeArmsFODMAP, Gluten, Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Management of irritable bowel syndrome: a narrative review.Translational gastroenterology and hepatology · 2024
    Review
  12. Article
  13. FODMAPs-Do they really affect IBS symptoms?Frontiers in medicine · 2023
    Article
  14. Article
  15. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Elise NordinDepartment of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.ORCID 0000-0001-5317-3261
Carl BruniusDepartment of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.ORCID 0000-0003-3957-870X
Rikard LandbergDepartment of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.ORCID 0000-0002-6399-7608
Per M HellströmDepartment of Medical Sciences, Uppsala University, Uppsala, Sweden.ORCID 0000-0001-8428-0772
Chalmers University of Technology · SEUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIrritable bowel syndrome (IBS) has been associated with diets rich in fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs), and gluten. Most previous studies have been single-blind and have focused on the elimination of FODMAPs or provocation with single FODMAPs. The effect of gluten is unclear, large trials isolating the effect of gluten from that of FODMAPs are needed.

objectivesThe aims of this study were to ensure high intakes of a wide range of FODMAPs, gluten, or placebo, and to evaluate the effects on IBS symptoms using the IBS-severity scoring system (IBS-SSS).

methodsThe study was carried out with a double-blind, placebo-controlled, randomized 3-way crossover design in a clinical facility in Uppsala from September 2018 to June 2019. In all, 110 participants fulfilling the IBS Rome IV criteria, with moderate to severe IBS, were randomly assigned; 103 (90 female, 13 male) completed the trial. Throughout, IBS participants maintained a diet with minimal FODMAP content and no gluten. Participants were block-randomly assigned to 1-wk interventions with FODMAPs (50 g/d), gluten (17.3 g/d), or placebo, separated by 1-wk washout. All participants who completed ≥1 intervention were included in the intention-to-treat analysis.

resultsIn participants with IBS (n = 103), FODMAPs caused higher IBS-SSS scores (mean 240 [95% CI: 222, 257]) than placebo (198 [180, 215]; P = 0.00056) or gluten (208 [190, 226]; P = 0.013); no differences were found between the placebo and gluten groups (P = 1.0). There were large interindividual differences in IBS-SSS scores associated with treatment. No adverse events were reported.

conclusionIn participants with IBS, FODMAPs had a modest effect on typical IBS symptoms, whereas gluten had no effect. The large interindividual differences in responses to the interventions warrant further detailed studies to identify possible underlying causes and enable individual prediction of responses. This trial was registered at www.clinicaltrials.gov as NCT03653689.

Indexed as

AdultCross-Over StudiesDiet, Carbohydrate-RestrictedDiet, Gluten-FreeDouble-Blind MethodFemaleFermentationGlutensHumansIrritable Bowel SyndromeMaleMiddle AgedMonosaccharidesOligosaccharidesPolymersTreatment OutcomeGlutensMonosaccharidesOligosaccharidesPolymerspolyolcrossover trialdietdouble-blindfermentationFODMAPsfunctional gastrointestinal disorderglutenirritable bowel syndromepolyolssaccharides

Identifiers

PMID34617561
PMCPMC8827068
OpenAlexW3201842847

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.