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Can poop and blood predict autism? new study searches for early warning signs

NCT ID NCT04271774

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 344 infants with a sibling diagnosed with autism from birth to age three. Researchers collected blood, stool, urine, and saliva samples to find early biological markers that might predict autism. The goal is to better understand how autism develops and eventually find ways to prevent or ease its symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this research could lead to earlier detection of autism and eventually help develop ways to prevent or reduce autism-related symptoms.
What could go wrong
This is an observational study, not a treatment trial. The biomarkers identified may not reliably predict autism in all children, and any future solutions are years away.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

344 people

The number who actually took part.

Started

Jul 2019

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Up to 6 months

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * Infants older than 6 months of age * Inability or unwillingness of legal guardian/representative to give written informed consent

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder

Contacts and locations

Locations

  • 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

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