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Prevention of Celiac Disease in Skåne (PreCiSe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03562221
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : October 4, 2023
Sponsor:
Information provided by (Responsible Party):
Lund University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Celiac Disease in Children Other: Gluten free diet Dietary Supplement: Probiotics Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Celiac Disease in Skåne (in Swedish - Prevention av Celiaki i Skåne)
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Gluten free diet
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   4 Months to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562221


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

Locations
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Sweden
Clinical Research Center (CRC), Bldng 60:11 Recruiting
Malmö, Sweden, 20502
Contact: Carin Andrén Aronsson, PhD    +46 40391113    carin.andren_aronsson@med.lu.se   
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Daniel Agardh, PhD Lund University
More Information
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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03562221    
Other Study ID Numbers: 2018/61
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: October 4, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University:
coeliac disease
celiac disease autoimmunity
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases