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Prevention of Celiac Disease in Skåne
Sponsor: Lund University
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
Conditions
Interventions
Gluten free diet
Controlled gluten free diet
Probiotics
Capsules
Placebo
Capsules
Locations (1)
Clinical Research Center (CRC), Bldng 60:11
Malmo, Sweden