Clinical trialNCT04271774CompletedObservational

Genome Environment Microbiome and Metabolome in Autism Study

SponsorMassachusetts General HospitalEnrollment344Autism Spectrum Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Alessio Fasano, MD
Massachusetts General Hospital
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Ireland

National University of Ireland Galway
Galway, Ireland

Italy

the Azienda Sanitaria Locale Salerno
Salerno, Italy

United States

Massachusetts General Hospital for Children
Boston, Massachusetts, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Jul 2019
Primary completion: 31 Dec 2025
Completion: 31 Dec 2025
Last update posted: 15 Apr 2026
Registered enrollment: 344
Registry id: NCT04271774

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.