Genome Environment Microbiome and Metabolome in Autism Study

Completed

Conditions studied: Autism Spectrum Disorder

In brief

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 biomarkers predictive of autism development in the blood, stool, urine and saliva. The biomarkers identified in this project will contribute to a better understanding of the pathogenesis of ASD in at-risk children and possible solutions for alleviating and/or preventing ASD and ASD-related symptoms in patients in the future.

Key facts

Study ID

NCT04271774

Run by

Massachusetts General Hospital

People needed

344

Starts

2019-07-01

Expected to finish

2025-12-31

Last updated by the study team

2026-04-15

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Infants older than 6 months of age
• Inability or unwillingness of legal guardian/representative to give written informed consent

Where it is running

• Massachusetts General Hospital for Children — Boston, Massachusetts, United States
• National University of Ireland Galway — Galway, Ireland
• The Azienda Sanitaria Locale Salerno — Salerno, Italy

Full record on ClinicalTrials.gov

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