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Non Celiac Gluten Sensitivity, DBPCFC in Adolescents

NCT04639921 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-03-03

No results posted yet for this study

Summary

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.

Conditions

  • Non-celiac Gluten Sensitivity; Adolescents

Interventions

DIAGNOSTIC_TEST

positive test followed by gluten-free diet

DBPCFC with gluten

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Steffen Husby, M.D. · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
15 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2021-05-30
Completion
2021-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639921 on ClinicalTrials.gov