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RECRUITING
NCT07005414
PHASE2

Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models

Sponsor: Fei Li

View on ClinicalTrials.gov

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.

Official title: Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

3 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2025-06-04

Completion Date

2026-05-30

Last Updated

2025-06-12

Healthy Volunteers

No

Interventions

DRUG

Bumetanide

Participants will receive bumetanide (0.5mg bid) for a period of three months.

BEHAVIORAL

Treatment as usual (TAU)

Participants will undergo treatment as usual, such as behavioral interventions

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China