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Blood test predicts which kids may benefit from autism drug

NCT ID NCT07005414

Symptom relief Sponsor: Fei Li 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether bumetanide, a diuretic, can improve social skills in children with autism. Researchers used a blood test and machine learning to pick children likely to respond. 66 children aged 3-6 took bumetanide or standard behavioral therapy for three months. The goal was to see if social symptoms improved more with the drug.

What this could mean

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

Active substance
bumetanide
What this could lead to
If it works, this could point toward a personalized treatment for social impairment in some children with autism.
What could go wrong
This is a small Phase 2 trial with only 66 children, so results may not apply to everyone. Bumetanide is a diuretic and can cause side effects like dehydration or electrolyte imbalance.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

66 people

The number who actually took part.

Started

Jun 2025

Finished

Apr 2026

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.

Ages

3 to 6 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 between 3 and 6 years old * Meeting the ASD diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Meeting the ASD diagnostic criteria of the Diagnostic Observational Scale for Autism, Second Edition(ADOS-2) * CARS total score ≥ 30 * Identified as high responder to bumetanide by machine learning algorithms * Obtaining informed consent from the legal guardian Exclusion Criteria: * Liver and kidney dysfunction * With a history of allergy to sulfa drugs * History of neurological diseases such as epilepsy * Abnormal ECG * Diagnosed with genetic or chromosomal abnormalities * Brain structural abnormalities detected by MRI which required surgical intervention * Using the melatonin treatment for sleep disorders or withdrawal less than three weeks. * Received any new intervention within 8 weeks prior to enrollment

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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

Contacts and locations

Locations

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092, China

More trials for these conditions

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