NCT07005414CompletedPhase 2
Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models
Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
The objective of this study is to learn if bumetanide could alleviate the clinical symptoms in children with autism spectrum disorder (ASD), who has been predicted as high responders to bumetanide via a cytokine-based predictive model. The Eligible ASD participants identified as high responder to bumetanide will be randomly assigned to either the experimental group or the control group. Participants in the experimental group will receive bumetanide interventions, along with the behavioral interventions, for three months. Participants in the control group will only undergo behavioral interventions. The clinical symptoms and potential adverse effects will be closely monitored throughout the intervention period.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 25 May 2025
- Start date
- 4 Jun 2025
- Primary completion date
- 21 Apr 2026
- Lead sponsor
- Fei Li
- Diseases
- Autism
- NCT number
- NCT07005414
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 66
- From 4 Jun 2025 to the primary completion date, 21 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Brain structural abnormalities detected by MRI which required surgical intervention
- Received any new intervention within 8 weeks prior to enrollment
Other illness
- With a history of allergy to sulfa drugs
- History of neurological diseases such as epilepsy
- Using the melatonin treatment for sleep disorders or withdrawal less than three weeks.
Other
- Liver and kidney dysfunction
- Abnormal ECG
- Diagnosed with genetic or chromosomal abnormalities
Who the study is looking for
- 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
Age in the registry: 3 years to 6 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.