NCT04271774Completed
Genome Environment Microbiome and Metabolome in Autism Study
Genome Environment Microbiome and Metabolome in Autism
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 344 (actual)
- First submitted
- 12 Feb 2020
- Start date
- 1 Jul 2019
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Autism
- NCT number
- NCT04271774
What you commit to
- Study type: Observational
- Participants enrolled: 344
- From 1 Jul 2019 to the primary completion date, 31 Dec 2025
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Infants older than 6 months of age
Other
- Inability or unwillingness of legal guardian/representative to give written informed consent
Who the study is looking for
- 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)
Age in the registry: - to 6 months · Sex: All
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National University of Ireland Galway Coordinator of this site? Confirm its status | Galway | Ireland | Unknown status |
| The Azienda Sanitaria Locale Salerno Coordinator of this site? Confirm its status | Salerno | Italy | Unknown status |
| Massachusetts General Hospital for Children Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.