Status:
ACTIVE_NOT_RECRUITING
Genome Environment Microbiome and Metabolome in Autism Study
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Azienda Sanitaria Locale Salerno
National University of Ireland, Galway, Ireland
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
Up to 6 years
Brief Summary
GEMMA is a multicenter longitudinal observational study that follows children who are genetically at-risk of developing autism for their first three years of life, seeking to identify potential biomar...
Detailed Description
The GEMMA study will address genomic, environmental, microbiome, and metabolomic factors that may affect the development of autism spectrum disorders (ASD). Genome: The project will study children wh...
Eligibility Criteria
Inclusion
- Healthy newborns and infants less than 6 months of age who have not been introduced to solid foods (elementary formula feeding is permitted)
- First-degree relatives of ASD individuals (at least one sibling affected by ASD)
Exclusion
- Infants older than 6 months of age
- Inability or unwillingness of legal guardian/representative to give written informed consent
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04271774
Start Date
July 1 2019
End Date
December 31 2025
Last Update
December 24 2025
Active Locations (3)
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1
Massachusetts General Hospital for Children
Boston, Massachusetts, United States, 02114
2
National University of Ireland Galway
Galway, Ireland, H91 TK33
3
The Azienda Sanitaria Locale Salerno
Salerno, Italy, 84124