NCT04271774|Completed
Genome Environment Microbiome and Metabolome in Autism Study
GEMMA
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GEMMA
Sponsor study identifier
observational
344
3 countries
3
Study Start
July 1, 2019
Actual (reported)Primary Completion
December 31, 2025
Actual (reported)Study Completion
December 31, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2019
Actual (reported)February 12, 2020
Actual (reported)February 17, 2020
Actual (reported)December 31, 2025
Actual (reported)December 31, 2025
Actual (reported)Use of microbiome/metagenomics/metatrancriptomic analysis to identify through our proposed prospective study and validate through large existing microbiome projects multi-omic biomarker predictors of ASD in at-risk infants.
i.e. stool and urine metabolites, alteration of gut permeability (via serum zonulin levels), abnormal immune response to dietary proteins (via IgA and IgG levels) and increased low-grade chronic inflammation (via serum pro-inflammatory cytokines).
5 years
Infants, enrolled at 0-6 months of age, who have a sibling diagnosed with ASD.
Newborns and infants less than 6 months of age who are first-degree relatives of ASD individuals (at least one sibling with an ASD diagnosis) are eligible for participation.
Massachusetts General Hospital for Children
Boston, Massachusetts, 02114, United States
National University of Ireland Galway
Galway, H91 TK33, Ireland
The Azienda Sanitaria Locale Salerno
Salerno, 84124, Italy
Periodic collection of blood, stool, urine and saliva samples from enrolled infant. One-time collection of blood, stool, urine and saliva samples from enrolled infant's ASD sibling and parent(s).
Alessio Fasano, MD
Massachusetts General Hospital
344 participants (actual enrollment reported by the registry).
First Submitted
February 12, 2020
First Posted
February 17, 2020
Study Start
July 1, 2019
Actual (reported)Mentorship Program for Individuals With Autism Spectrum Disorder (ASD)
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2025
Actual (reported)Study Completion
December 31, 2025
Actual (reported)Last Updated
April 15, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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