Prevention of Celiac Disease in Skåne (PreCiSe)
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- STATUS
- Recruiting
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- End date
- Aug 19, 2027
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- participants needed
- 600
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- sponsor
- Lund University
Summary
This study aims to investigate the impact on 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.
Study participants will be randomly allocated to one of the three study groups before the age of 4 months and will remain in that group with the corresponding intervention during the three first years of life.
Regular visits to a study nurse and contact with study dietician will be scheduled. The dietician will support the families in keeping the correct diet intended for each study group.
Description
The primary hypothesis to be tested is that a strictly gluten free diet during the first three years of life with a slow introduction of gluten during the follow-up period will induce tolerance to gluten. A similar hypothesis is tested if a daily supply of two different lactobacillus (LB) strains can suppress an inflammatory response to gluten in the intestine by stimulating regulatory T-cells and reduced permeability of gluten peptides in the intestine.
The secondary hypothesis tested is that celiac disease can not be prevented, but the onset of the disease will be delayed in children returning to a gluten-containing diet after the intervention period (gluten free diet) or probiotic treatment) during the first three years of life. The intervention period is 3 years and the follow-up period is further 4 years.
The primary aim is to study the proportion of children who develop celiac disease autoimmunity and progression to celiac disease by the age of 3 years. Secondary aim is to study the proportion of children who developed celiac disease at the age of 7 years.
Details
| Condition | Celiac Disease in Children |
|---|---|
| Treatment | Placebo, Gluten free diet, probiotics |
| Clinical Study Identifier | NCT03562221 |
| Sponsor | Lund University |
| Last Modified on | 19 April 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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