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Active, Not Recruiting

NCT Number: NCT03562221

Prevention of Celiac Disease in Skåne

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

4 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center (CRC), Bldng 60:11

Malmö, 20502, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten free diet

Other

Controlled gluten free diet

Probiotics

Dietary Supplement

Capsules

Placebo

Dietary Supplement

Capsules

Primary outcomes

  1. Number of children tested positive for persistent tissue transglutaminase (tTG) autoantibodies, defined as celiac disease autoimmunity

    Time frame: from 4 months of age up until 7 years of age

    Radioligand binding assays (RBA) will be used to measure tTG autoantibodies in serum samples collected every third months up until the age of 3 years and then annually up until the age of 7 years.

Secondary outcomes

  1. Number of children diagnosed with celiac disease

    Time frame: Up until 7 years of age

    A celiac disease diagnose will be defined by an intestinal biopsy showing a Marsh score of 2 or higher or by high levels of tTG autoantibodies (> 100 units) in at least 2 consecutive blood samples.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

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

Acronym: PreCiSe

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jun 19, 2018
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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