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Gut-Brain link explored in 600 kids with autism

NCT ID NCT07646808

Knowledge-focused Sponsor: Saveetha University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how the tiny organisms in the gut (the microbiome) are connected to brain development and daily skills in children with autism. Researchers will collect stool samples and measure movement, thinking, and behavior in 600 children aged 3 to 12. The goal is to better understand this gut-brain connection, which could lead to more personalized therapies in the future.

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

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

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

The study population will consist of children aged 3 to 12 years with a confirmed diagnosis of Autism Spectrum Disorder (ASD) who are receiving care at participating pediatric rehabilitation, developmental, neurology, psychiatry, and autism care centers. Eligible participants will undergo stool sample collection for gut microbiome analysis and multidomain neurodevelopmental assessment, including evaluation of autism severity, gross motor function, sensory processing, cognitive functioning, behavioral function, sleep, participation, quality of life, gastrointestinal symptoms, dietary intake, and anthropometric nutritional status. Written informed consent will be obtained from parents or legal guardians prior to participation.

Ages

3 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Children aged 3 to 12 years * Clinical diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5/ICD criteria and confirmed from medical records or specialist assessment * Stable clinical status at the time of enrollment * Parent/legal guardian willing to provide written informed consent * Child able to undergo stool sample collection and neurodevelopmental assessments * Parent/caregiver able to complete questionnaires and provide dietary and medical history Exclusion Criteria: * Use of systemic antibiotics, probiotics, prebiotics, synbiotics, or bowel-cleansing agents within the previous 4-12 weeks before stool collection * Presence of acute gastrointestinal infection or acute febrile illness at the time of assessment * Known chronic gastrointestinal disorders that may independently alter the gut microbiome, such as inflammatory bowel disease, celiac disease, short bowel syndrome, or chronic intestinal malabsorption * Major neurological, genetic, or metabolic disorders other than ASD that may independently affect neurodevelopment * Current use of medications known to significantly affect gut microbiota or bowel motility, if clinically relevant to your protocol * Inability to provide stool sample or complete the required assessments * Refusal of consent by parent/legal guardian

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

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

Autism spectrum disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Saveetha Medical College and Hospital

    Chennai, Tamil Nadu, 602 105, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.