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Prevention of Celiac Disease in Skåne

Study acronym: PreCiSe
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study completion pushed from Aug 2027 to Aug 2030v10
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 600 to confirmed 220
    • Site details revised
    v9
  3. Re-verified, no change to tracked fieldsv8
  4. Primary completion date: Aug 2024 to Aug 2027v7
  5. 4 versions Re-verified since Feb 25, 2020, no change to tracked fieldsv3-v6
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2018 to Dec 4, 2018
    • Study sites: 0 to 1
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT03562221
Lead Sponsor Lund University
Conditions
(from sponsor)		 Celiac Disease in Children
Related terms Celiac Disease
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov