Study of factors influencing celiac disease in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CDGEMM study investigates the interplay of genomic, environmental, microbiome, and metabolomic factors in the development of celiac disease (CD) among infants. It focuses on newborns with a first-degree relative diagnosed with CD, examining how genetic predispositions and environmental influences, such as birth method and antibiotic use, contribute to disease risk. The study will follow these infants until they are five years old, collecting data on their health and dietary habits to identify potential predictors of CD. By understanding these factors, the study aims to enhance early detection and prevention strategies for high-risk children.

Why it matters

Who can join: the full rules

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

Where it's running

• MassGeneral Hospital for Children
  Boston, Massachusetts, United States Recruiting
• University of Roma La Sapienza
  Rome, Italy Recruiting

Study contacts

• Principal investigator: Maureen Leonard, MD — Massachusetts General Hospital
• Study coordinator: Victoria Kenyon, MHA
• Email: vakenyon@mgb.org
• Phone: 617-643-4366

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mediterranean diet and processed food in adults with celiac disease on a gluten-free diet

  This observational study looks at whether following a Mediterranean-style diet or eating more highly processed foods affects GI symptoms and quality of life in adults with celiac disease who have been on a strict gluten-free diet.

  Recruiting at 7 sites Istituti Clinici Scientifici Maugeri SpA · Brescia, BS and 6 other locations · NCT07915063

• Exercise for Metabolic Syndrome and Fatty Liver in Adolescent Girls with Celiac Disease

  This study tests whether a 3-month walking program helps improve metabolic syndrome and fatty liver in adolescent females with celiac disease.

  Recruiting Cairo University · Giza, Dokki · NCT07832994

• Nutrition and physical activity education for children with celiac disease

  This study tests whether a combined nutrition and physical activity education program helps 8- to 12-year-olds with celiac disease improve body health, eating habits, activity, and quality of life while on a gluten-free diet.

  Recruiting Bahçeşehir University · Istanbul, Besiktas · NCT07750795

• Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity

  This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.

  Recruiting at 2 sites University of Palermo · Palermo, Palermo and 1 other locations · NCT07750535

• Omega-3 fats to reduce inflammation in adults with newly diagnosed celiac disease

  This study tests whether adding omega-3 fatty acid supplements to a gluten-free plan helps reduce inflammation and promote intestinal healing in adults who have just been diagnosed with celiac disease.

  Recruiting University of Chile · Santiago, Metropolitan Region · NCT07585669

• Wheat sensitivity or IBS/functional dyspepsia in relatives of people with celiac disease

  This project will test whether adults related to celiac patients have higher rates of non-celiac wheat sensitivity or IBS/functional dyspepsia and whether symptoms change on a wheat-free diet.

  Recruiting at 2 sites University of Palermo · Palermo, PA and 1 other locations · NCT07584473

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.