Prevention of Celiac Disease in Skåne

Last updated: August 18, 2025
Sponsor: Lund University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Celiac Disease

Treatment

Placebo

Gluten free diet

Probiotics

Clinical Study ID

NCT03562221
2018/61
  • Ages 4-4
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 consumptionhas started).

Exclusion

Exclusion Criteria:

  • Congenital chronic disorder where intervention with diet or probiotics may beaffected.

  • Written consent from both caregivers are missing

Study Design

Total Participants: 220
Treatment Group(s): 3
Primary Treatment: Placebo
Phase:
Study Start date:
December 04, 2018
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • Clinical Research Center (CRC), Bldng 60:11

    Malmo 2692969, 20502
    Sweden

    Site Not Available

  • Clinical Research Center (CRC), Bldng 60:11

    Malmö, 20502
    Sweden

    Site Not Available

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