Evidence map›Paper›PMID 35352373›Full record

Trial reportAlimentary pharmacology & therapeutics2022

The effect of gluten in adolescents and young adults with gastrointestinal symptoms: a blinded randomised cross-over trial.

Caecilie Crawley, Nadia Savino, Cecilie Halby, Stine Dydensborg Sander, Anne-Marie Nybo Andersen, Manimozhiyan Arumugam, Joseph Murray, Robin Christensen, Steffen Husby

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04639921 (Non Celiac Gluten Sensitivity, a Double Blind Placebo Controlled Food Challenge With Cross-over in Healthy Danish Adolescents), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% 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.

NCT04639921 naunknown statusnot on this map

Non Celiac Gluten Sensitivity, a Double Blind Placebo Controlled Food Challenge With Cross-over in Healthy Danish Adolescents

TypeinterventionalSponsorOdense University HospitalRan2020 to 2021Enrolled33ConditionsNon-celiac Gluten Sensitivity, AdolescentsArmspositive test followed by gluten-free diet, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 2 countries.

Caecilie CrawleyHans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.ORCID 0000-0001-7526-8843
Nadia SavinoHans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.
Cecilie HalbyHans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.
Stine Dydensborg SanderHans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.
Anne-Marie Nybo AndersenSection of Epidemiology, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Manimozhiyan ArumugamNovo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Joseph MurrayDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0003-1941-9090
Robin ChristensenSection for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
Steffen HusbyHans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.
University of Southern Denmark · DKUniversity of Copenhagen · DKMayo Clinic · USOdense University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe popularity of the gluten-free diet and sales of gluten-free products have increased immensely.

aimsTo investigate whether gluten induces gastrointestinal symptoms, measured by self-reported questionnaires, as well as mental health symptoms in adolescents from a population-based cohort.

methodsThe eligible participants (n = 273) were recruited from a population-based cohort of 1266 adolescents and had at least four different gastrointestinal symptoms. Phase one (n = 54) was a run-in phase where the participants lived gluten-free for 2 weeks. If they improved they continued to phase 2 (n = 33), a blinded randomised cross-over trial. Participants were blindly randomised either to start with 7 days of gluten, eating two granola bars containing 10 g of gluten or to 7 days on placebo, eating two granola bars without gluten, followed by the reverse and separated by a 7-day washout period. The effects of the intervention on gastrointestinal symptoms and mental health symptoms were assessed.

resultsIn total, 54/273 participants entered the run-in phase and 35 were eligible for randomization. A total of 33 were randomised and 32 completed the trial. The median age was 20.3 (IQR 19.2-20.9) and 32/33 participants were females. Compared with a placebo, gluten did not induce gastrointestinal symptoms. The difference in the average VAS was -0.01 (95% confidence interval -2.07 to 2.05). Nor did we find a difference in the outcomes measuring mental health.

conclusionCompared with placebo, adding gluten to the diet did not induce gastrointestinal symptoms or worsened mental health in adolescents recruited from a population-based cohort. The trial registration number is NCT04639921.

Indexed as

Celiac DiseaseGastrointestinal DiseasesAdolescentAdultCross-Over StudiesDiet, Gluten-FreeDouble-Blind MethodFemaleGlutensHumansMaleYoung AdultGlutensglutengluten-free dietgluten sensitivity enteropathy

Identifiers

PMID35352373
PMCPMC9313792
OpenAlexW4220936724

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.