Prevention of Celiac Disease in Skåne (PreCiSe)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Celiac Disease in Children
• Intervention / Treatment: Other: Gluten free diet; Dietary supplement: Probiotics; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carin A Aronsson, PhD; Phone Number: +46708876649; Email: carin.andren_aronsson@med.lu.se

Study Locations

• Sweden
  • Malmö, Sweden, 20502
    • Recruiting
    • Clinical Research Center (CRC), Bldng 60:11
    • Contact: Carin Andrén Aronsson, PhD; Phone Number: +46 40391113; Email: carin.andren_aronsson@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 4 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gluten free diet	Other: Gluten free diet; Controlled gluten free diet
Active Comparator: 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.	Dietary supplement: Probiotics; Capsules
Placebo Comparator: Placebo; Placebo capsules with maize starch and without any bacteria.	Dietary supplement: Placebo; Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lund University
• Investigators: Principal Investigator: Daniel Agardh, PhD, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: coeliac disease; celiac disease autoimmunity
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: 2018/61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No