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

Completed · Phase 1 · Has a placebo group

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT03337035

Run by

Massachusetts General Hospital

People needed

35

Starts

2018-12-01

Expected to finish

2019-10-02

Last updated by the study team

2020-03-04

Who can join

Age: 3 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 3-25years old;
• Pre-existing diagnosis of autism; subjects may be asked to provide documentation confirming diagnosis by DSM-V-TR criteria, ADOS, ADI-R, or other clinical forms
• A care provider who can reliably bring the participant to study visits;
• No planned changes in medications or psychosocial interventions during trial (stable medications within the last 2 weeks);
• Willingness to provide blood samples

You may not qualify if…

• Pregnant woman (before or during the study).
• Comorbidity of other neurological and/or psychiatric disorders such as unstable seizures, schizophrenia, schizoaffective disorder, bipolar disorders or history of substance abuse.
• Psychotropic medication use
• Subjects with active cardiovascular disease that is not controlled by medication.
• Oxytocin, antibiotic, or probiotic use within the last 30 days.
• Regular nasal obstruction or nosebleeds
• Significant hearing, vision, or motor impairments
• Habitual consumption of large volumes of water
• Started taking new medications within the last 2 weeks

Where it is running

• Massachusetts General Hospital — Charlestown, Massachusetts, United States

Full record on ClinicalTrials.gov

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