Prevention of Celiac Disease in Skåne (PreCiSe)

  • End date
    Aug 19, 2027
  • participants needed
  • sponsor
    Lund University
Updated on 19 April 2022
Accepts healthy volunteers


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.


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.

Condition Celiac Disease in Children
Treatment Placebo, Gluten free diet, probiotics
Clinical Study IdentifierNCT03562221
SponsorLund University
Last Modified on19 April 2022


Yes No Not Sure

Inclusion Criteria

Children screened positive for human leucocyte antigen (HLA) DR3-DQ2/DR3-DQ2
Children must be enrolled to the study by 4 months of age (before gluten consumption has started)

Exclusion Criteria

Congenital chronic disorder where intervention with diet or probiotics may be affected
Written consent from both caregivers are missing
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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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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