Prevention of Celiac Disease in Skåne
PreCiSe
1 other identifier
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedStudy Start
First participant enrolled
December 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
August 22, 2025
August 1, 2025
8.7 years
May 21, 2018
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of children diagnosed with celiac disease
Up until 7 years of age
Study Arms (3)
Gluten free diet
EXPERIMENTALGluten free diet
Probiotics
ACTIVE COMPARATORCapsules 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 COMPARATORPlacebo capsules with maize starch and without any bacteria.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Congenital chronic disorder where intervention with diet or probiotics may be affected.
- Written consent from both caregivers are missing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (1)
Clinical Research Center (CRC), Bldng 60:11
Malmo, 20502, Sweden
Related Publications (1)
Af Segerstad EMH, Ericson-Hallstrom E, Bokstrom A, Armeni M, Savolainen O, Andren Aronsson C. Plasma Alkylresorcinols Is an Objective Biomarker for Gluten Intake in Young Children. J Nutr. 2025 Mar;155(3):985-993. doi: 10.1016/j.tjnut.2025.01.020. Epub 2025 Jan 27.
PMID: 39880171DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Agardh, PhD
Lund University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2018
First Posted
June 19, 2018
Study Start
December 4, 2018
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
August 22, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share