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ACTIVE NOT RECRUITING
NCT03562221
NA

Prevention of Celiac Disease in Skåne

Sponsor: Lund University

View on ClinicalTrials.gov

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.

Official title: Prevention of Celiac Disease in Skåne (in Swedish - Prevention av Celiaki i Skåne)

Key Details

Gender

All

Age Range

4 Months - 4 Months

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2018-12-04

Completion Date

2027-08

Last Updated

2025-08-22

Healthy Volunteers

Yes

Interventions

OTHER

Gluten free diet

Controlled gluten free diet

DIETARY_SUPPLEMENT

Probiotics

Capsules

DIETARY_SUPPLEMENT

Placebo

Capsules

Locations (1)

Clinical Research Center (CRC), Bldng 60:11

Malmo, Sweden