Prevention of Celiac Disease in Skåne

Not Applicable

Recruiting

• Conditions: Celiac Disease in Children
• Interventions: Other: Gluten free diet; Dietary Supplement: Probiotics; Dietary Supplement: Placebo

• Registration Number: NCT03562221
• Lead Sponsor: Lund University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-21
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-19
• Study Start: 2018-12-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gluten free diet	Gluten free diet	Gluten free diet
Probiotics	Probiotics	Capsules with a combination of two probiotic bacteria with maize starch as excipient and at a total dose of 10(10) colony forming units (CFU)/capsule.
Placebo	Placebo	Placebo capsules with maize starch and without any bacteria.

Primary Outcome Measures

Name	Time	Method
Number of children tested positive for persistent tissue transglutaminase (tTG) autoantibodies, defined as celiac disease autoimmunity	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 Outcome Measures

Name	Time	Method
Number of children diagnosed with celiac disease	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.

Trial Locations

Locations (1)

Clinical Research Center (CRC), Bldng 60:11; 🇸🇪 Malmö, Sweden