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NCT04271774 · ClinicalTrials.gov registry record
Genome Environment Microbiome and Metabolome in Autism Study
A clinical trial of Autism Spectrum Disorder, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- 600
- Enrollment target
- 3
- Study locations
NCT04271774: Active study of Autism Spectrum Disorder, sponsored by Massachusetts General Hospital.
NCT04271774 is a study of Autism Spectrum Disorder that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 600 participants, above the 133-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (351% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04271774, a study of Autism Spectrum Disorder, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 600 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
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).
Conditions Studied
Study Locations (3)
Other
- National University of Ireland Galway - Galway
- The Azienda Sanitaria Locale Salerno - Salerno
Massachusetts
- Massachusetts General Hospital for Children - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2025-12-31 |
What the registry record for NCT04271774 still lists
NCT04271774 is an observational study that tracks outcomes without assigning an intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (351% higher).
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 0 interventions.
NCT04271774 reports a single indexed study location in Other, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04271774 about?
NCT04271774 is a clinical study titled "Genome Environment Microbiome and Metabolome in Autism Study". 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 identifi...
What is the current status of trial NCT04271774?
This trial is currently active not recruiting. The enrollment target is 600 participants. The study started on 2019-07-01. Estimated completion is 2025-12-31.
What conditions does trial NCT04271774 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder.
Who is sponsoring clinical trial NCT04271774?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04271774 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04271774's enrollment target sits among peer trials
600 8th of 224 higher than 217 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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