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Gluten Reduction and Risk of Celiac Disease

NCT04593888 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1141

Last updated 2026-04-13

No results posted yet for this study

Summary

Celiac disease shares many features of other autoimmune diseases such as type 1 diabetes. Recently, it was published that higher amounts of gluten intake increased the risk for celiac disease. Optimal amounts of gluten to be introduced during weaning have not yet been established. The aim is to investigate if a gluten-restricted diet (e.g. below 3 gram per day) during the first 3 years of life will reduce the risk of develop CDA and IA in genetically predisposed children by the age of 7 years. Children who screened positive for HLA DQ2/X (X is neither DQ2 nor DQ8) in the GPPAD-02 (ASTR1D \[ClinicalTrials.gov Identifier NCT03316261\]) screening will be contacted by a study nurse.

Conditions

Interventions

BEHAVIORAL

Gluten reduced diet

Dietary advice focusing on reducing gluten intake in children

Sponsors & Collaborators

  • Lund University

    lead OTHER

Principal Investigators

  • Daniel Agardh, MD, PhD · Lund University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2030-12-31
Completion
2035-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT04593888 on ClinicalTrials.gov