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
Fei Li
66 participants
Jun 4, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria8
- 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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Interventions
Participants will receive bumetanide (0.5mg bid) for a period of three months.
Participants will undergo treatment as usual, such as behavioral interventions
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07005414