Prevention of Celiac Disease in Skåne

Celiac Disease in Children Clinical Trial

— PreCiSe  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03562221
• Other study ID #: 2018/61
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: August 2027

Study information

• Verified date: October 2023
• Source: Lund University
• Contact: Carin A Aronsson, PhD
• Phone: +46708876649
• Email: carin.andren_aronsson[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2027
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease
• Celiac Disease in Children

Intervention

Other:
• Gluten free diet
Controlled gluten free diet

Dietary Supplement:
• Probiotics
Capsules
• Placebo
Capsules

Locations

Country	Name	City	State
Sweden	Clinical Research Center (CRC), Bldng 60:11	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of children tested positive for persistent tissue transglutaminase (tTG) autoantibodies, defined as celiac disease autoimmunity	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.	from 4 months of age up until 7 years of age
Secondary	Number of children diagnosed with celiac disease	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.	Up until 7 years of age