Trial · NCT07005414
Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models
NCT07005414, Phase 2, Completed, Fei Li
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models. Trials, record NCT07005414. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07005414
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models
- NCT number
- NCT07005414
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Fei Li
- Conditions
- Autism Spectrum Disorder
- Interventions
- Bumetanide, Treatment as usual (TAU)
- First posted
- 2025-06-05
- Last updated
- 2026-04-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Social Responsiveness Scale, Second Edition (SRS-2) | From enrollment to the end of treatment at 3 months | Social Responsiveness Scale, Second Edition (SRS-2) is a scale used to evaluate the presence and severity of social impairment. The scores of the SRS-2 rate from 0 to 195, and higher scores indicate more severe symptoms. Changes of the SRS-2 scores from baseline to 3 month after treatment will be analyzed to assess the effect of the intervention on children with ASD. |
| Secondary | Clinical Global Impressions Scale (CGI) | From enrollment to the end of treatment at 3 months | Clinical Global Impressions Scale (CGI) is a scale used to assess the severity of the illness and the global improvement of the participants under intervention.The Clinical Global Impression - Severity scale (CGI-S) is a clinician rated 7-point measure of overall severity. Scores range from 1 (Normal, not at all ill) through 4 (Moderately ill) to 7 (Among the most extremely ill patients). The Clinical Global Impression - Improvement scale (CGI-I) is the companion measure that evaluates the change in the patient's symptoms relative to baseline. Scores range from 1 (Very much improved) through 4 (No Change) to 7 (Very much worse). |
| Secondary | Vineland Adaptive Behavior Scale | From enrollment to the end of treatment at 3 months | The VABS is used to measure adaptive functioning across domains such as communication, daily living skills, socialization, and motor skills. Changes in VABS scores from baseline to 3 months post-treatment will be analyzed to assess the intervention's impact on adaptive behaviors in children with ASD. |
| Secondary | Childhood Autism Rating Scale (CARS) | From enrollment to the end of treatment at 3 months | CARS is a behavior-rating scale used to assess the presence and severity of the symptoms associated autism spectrum disorder. The scores of the CARS rate from 15 to 60, and higher scores indicate more severe symptoms. The changes in the CARS scores from baseline to 3 months after the treatment will be analyzed to assess the impact of the intervention on participants with ASD. |
| Secondary | Aberrant Behavior Checklist (ABC) | From enrollment to the end of treatment at 3 months | Aberrant Behavior Checklist (ABC) is a 58-item instrument used to measure behavior problems across five sub-scales: hyperactivity, irritability, social withdrawal, stereotypic behavior and inappropriate speech. Each item rates behavior severity on a 4 point scale from 0 (Not at all a problem) to 3 (The problem is severe in degree). A higher score indicates more frequent aberrant behaviors.Changes of the total scores and scores of subscales from baseline to 3 month after treatment will be analyzed. |
| Secondary | Chinese Communicative Development Inventory (CCDI) | From enrollment to the end of treatment at 3 months | Chinese Communicative Development Inventory (CCDI) is a questionnaire used to measures the language abilities. Higher scores suggest better language level. The changes in the CCDI between baseline and 3 month after treatment will be analyzed. |
| Other | Biomarkers (single nucleotide polymorphisms) | From enrollment to the end of treatment at 3 months | Blood samples will be collected at baseline. Depending on funding availability, whole genome sequencing may subsequently be performed. If sequencing is conducted, a genome-wide association study will be carried out to investigate potential correlations between genetic polymorphisms and response to bumetanide treatment. |
| Other | Biomarkers (metabolites) | From enrollment to the end of treatment at 3 months | Blood samples will be collected at baseline and at the 3-month follow-up. Depending on funding availability, targeted metabolomics may subsequently be performed, covering free fatty acids, bile acids and amino acids profiling. Changes in the levels of metabolites between baseline and 3 months after treatment will be analyzed. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07005414
GET https://conductscience.org/api/trials/v1/NCT07005414/registered