Genome Environment Microbiome and Metabolome in Autism Study

NCT04271774 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 344

Last updated 2026-04-15

No results posted yet for this study

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 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.

Conditions

Sponsors & Collaborators

  • Azienda Sanitaria Locale Salerno

    collaborator OTHER
  • National University of Ireland, Galway, Ireland

    collaborator OTHER
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Alessio Fasano, MD · Massachusetts General Hospital

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States
  • Ireland
  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04271774 on ClinicalTrials.gov