drugset / Trial / NCT03337035

Probiotics and Oxytocin Nasal Spray on Social Behaviors of Autism Spectrum Disorder (ASD) Children

NCT03337035

Phase 1 Completed 35 enrolled Massachusetts General Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

Because oral probiotics reported to potentially induce endogenous Oxytocin, and Oxytocin has been reported to improve social behaviors, the investigators will conduct a pilot trial to compare the effects of probiotics and Oxytocin on social behavioral changes in ASD children. Additionally, the investigators will check oxytocin levels, and perform brain fMRI in some subjects, in order to determine which treatment is more efficient, sustainable, and practical, and whether both treatments in combination are better than either treatment alone. If the trial is conclusive, the investigators will conduct a trial in large scale to understand more the mechanism of ASD behaviors and corresponding effective interventions.

Timeline

Start
2018-12-01
Primary completion
2019-10-02
Completion
2019-10-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxytocin Peptide 24 iu Intranasal