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NCT04639921

Non Celiac Gluten Sensitivity, DBPCFC in Adolescents

Status unknown NA Last updated 3 March 2021
What this trial tests

NA trial testing positive test followed by gluten-free diet in Non-celiac Gluten Sensitivity; Adolescents in 33 participants. Status unknown.

Timeline
15 October 2020
Primary endpoint
30 May 2021
30 June 2021

Quick facts

Lead sponsorOdense University Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingtriple
Primary purposediagnostic
Enrollment33
Start date15 October 2020
Primary completion30 May 2021
Estimated completion30 June 2021
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Odense University Hospital

Who can join

Adults 15 to 21, any sex, with Non-celiac Gluten Sensitivity; Adolescents. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In a population based on healthy adolescents we will conduct a double blind placebo controlled food challenge (DBPCFC) with cross-over to identify patients with NCGS as recommended by the socalled Salerno criteria. It will take place at Hans Christian Andersen Childrens Hospital at Odense University Hospital, Denmark in October-November 2020.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The effect of gluten in adolescents and young adults with gastrointestinal symptoms: a blinded randomised cross-over trial.
    Crawley C, Savino N, Halby C, Sander SD, et al · · 2022 · cited 13× · PMID 35352373 · DOI 10.1111/apt.16914

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Trials by the same sponsor.

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