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Prevention of Celiac Disease in Skåne

NCT03562221 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-08-22

No results posted yet for this study

Summary

This study aims to investigate the impact of being on a gluten free diet the first three years of life compared to a daily intake of a probiotic supplementation or placebo on the risk of developing celiac disease autoimmunity or celiac disease in genetically susceptible children.

This is a three-arm (1:1:1) randomized trial where study participants are randomly allocated to one of the three study groups before the age of 4 months. Regular clinical visits (4 times/year) during the intervention phase and yearly there after, up to the age of 7 years.

Conditions

  • Celiac Disease in Children

Interventions

OTHER

Gluten free diet

Controlled gluten free diet

DIETARY_SUPPLEMENT

Probiotics

Capsules

DIETARY_SUPPLEMENT

Placebo

Capsules

Sponsors & Collaborators

  • Lund University

    lead OTHER

Principal Investigators

  • Daniel Agardh, PhD · Lund University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
4 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-04
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Sweden

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 NCT03562221 on ClinicalTrials.gov