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Search / Trial NCT03562221

Prevention of Celiac Disease in Skåne

Launched by LUND UNIVERSITY · Jun 7, 2018

Trial Information

Current as of June 25, 2025

Recruiting

Keywords

Coeliac Disease Celiac Disease Autoimmunity

ClinConnect Summary

The "Prevention of Celiac Disease in Skåne" trial is studying how different diets might affect the risk of developing celiac disease in children who are genetically at risk. Specifically, the trial compares a gluten-free diet during the first three years of life with daily probiotic supplements or a placebo (a non-active treatment). This study is important because it aims to find out which approach, if any, can help prevent celiac disease, a condition where the body has a bad reaction to gluten, a protein found in wheat and other grains.

To participate in this study, children must be less than 4 months old and have a specific genetic marker (HLA DR3-DQ2/DR3-DQ2) that makes them more likely to develop celiac disease. Families will have regular check-ins with healthcare providers four times a year during the study, and once a year afterward, until the child turns 7. It’s also important for parents to know that children with certain health conditions or without proper consent from both caregivers cannot join the study. This trial is currently recruiting participants, and it offers a chance to contribute to important research that could help improve the lives of children at risk for celiac disease.

Gender

ALL

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

About Lund University

Lund University, a prestigious research institution in Sweden, is renowned for its commitment to advancing scientific knowledge and innovation in healthcare. With a strong emphasis on interdisciplinary collaboration, the university conducts cutting-edge clinical trials aimed at addressing critical health challenges. Leveraging its state-of-the-art facilities and a diverse network of expert researchers, Lund University strives to translate research findings into effective therapeutic solutions, ultimately improving patient outcomes and enhancing public health. Through its dedication to ethical research practices and patient safety, Lund University plays a pivotal role in the global clinical research landscape.

Locations

Malmö, , Sweden

Patients applied

0 patients applied

Trial Officials

Daniel Agardh, PhD

Principal Investigator

Lund University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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