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Clinical Trial
. 2022 May;55(9):1116-1127.
doi: 10.1111/apt.16914. Epub 2022 Mar 29.

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

Caecilie Crawley  1   2 , Nadia Savino  1   2 , Cecilie Halby  1   2 , Stine Dydensborg Sander  1 , Anne-Marie Nybo Andersen  3 , Manimozhiyan Arumugam  4   5 , Joseph Murray  6 , Robin Christensen  7   8 , Steffen Husby  1   2
Affiliations
Clinical Trial

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

Caecilie Crawley et al. Aliment Pharmacol Ther. 2022 May.

Abstract

Background: The popularity of the gluten-free diet and sales of gluten-free products have increased immensely.

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

Methods: The 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.

Results: In 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.

Conclusion: Compared 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.

Keywords: gluten; gluten sensitivity enteropathy; gluten-free diet.

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Figures

FIGURE 1
FIGURE 1
A flow chart illustrating the trial profile
FIGURE 2
FIGURE 2
Average vas score (95% confidence intervals) between gluten and placebo. Values are least squares means (SE). Statistical tests are based on repeated‐measures linear mixed‐effects model (participants modelled as a random effects variable)
See this image and copyright information in PMC

Comment in

References

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