Prevention of Celiac Disease in Skåne (PreCiSe)

• ClinicalTrials.gov Identifier: NCT03562221
• Recruitment Status: Recruiting
• First Posted: June 19, 2018
• Last Update Posted: October 4, 2023
• Sponsor: Lund University
• Information provided by (Responsible Party): Lund University

Tracking Information

• First Submitted Date: May 21, 2018
• First Posted Date: June 19, 2018
• Last Update Posted Date: October 4, 2023
• Actual Study Start Date: December 4, 2018
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 7, 2018)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 7, 2018)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevention of Celiac Disease in Skåne
• Official Title: Prevention of Celiac Disease in Skåne (in Swedish - Prevention av Celiaki i Skåne)

Brief 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
• Condition: Celiac Disease in Children

Intervention

• Other: Gluten free diet
  Controlled gluten free diet
• Dietary Supplement: Probiotics
  Capsules
• Dietary Supplement: Placebo
  Capsules

Study Arms

• Experimental: Gluten free diet
  Gluten free diet
  Intervention: Other: 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.
  Intervention: Dietary Supplement: Probiotics
• Placebo Comparator: Placebo
  Placebo capsules with maize starch and without any bacteria.
  Intervention: Dietary Supplement: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 7, 2018): 600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2027
• Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Months to 4 Months (Child)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Carin A Aronsson, PhD; +46708876649; carin.andren_aronsson@med.lu.se

• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT03562221
• Other Study ID Numbers: 2018/61
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Lund University
• Original Responsible Party: Same as current
• Current Study Sponsor: Lund University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Daniel Agardh, PhD; Lund University

• PRS Account: Lund University
• Verification Date: October 2023