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Search / Trial NCT02061306

Celiac Disease Genomic Environmental Microbiome and Metabolomic Study

Launched by MASSACHUSETTS GENERAL HOSPITAL · Feb 10, 2014

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Celiac Disease Coeliac Disease Microbiome Gluten Infants Pregnancy Genetic

ClinConnect Summary

The Celiac Disease Genomic Environmental Microbiome and Metabolomic Study (CDGEMM) is a research trial aimed at understanding what causes celiac disease (CD). Celiac disease is a serious condition triggered by eating gluten, a protein found in foods like wheat, rye, and barley. This study will look at various factors—like genetics, diet, and the gut bacteria that live in our intestines—to see how they might increase the risk of developing CD. By identifying these risk factors, the researchers hope to improve ways to prevent or detect the disease, especially in children who may be more likely to develop it.

To participate in this study, you must be a newborn or infant under 6 months old who has not started eating solid foods yet, or a first-degree relative (like a parent or sibling) of someone with confirmed celiac disease. Unfortunately, infants older than 6 months or those whose guardians cannot provide consent are not eligible. If you join the study, you can expect to contribute to important research that may help future generations by providing insights into celiac disease and how to manage it better.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Newborns and infants less than 6 months of age who have not been introduced to solid foods (exclusive breast milk or formula diet)
  • First-degree relatives of patients affected with biopsy-proven CD
  • Exclusion Criteria:
  • Infants older than 6 months of age
  • Inability or unwillingness of legal guardian/representative to give written informed consent

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Rome, , Italy

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Alessio Fasano, MD

Principal Investigator

Massachusetts General Hospital

Maureen M. Leonard, MD

Study Chair

Massachusetts General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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