Overview

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

Status:
Completed
Trial end date:
2019-10-02
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Massachusetts General Hospital
Treatments:
Ascorbic Acid
Oxytocin
Vitamins
Criteria
Inclusion Criteria:

1. Age between 3-25years old;

2. 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

3. A care provider who can reliably bring the participant to study visits;

4. No planned changes in medications or psychosocial interventions during trial (stable
medications within the last 2 weeks);

5. Willingness to provide blood samples

Exclusion Criteria:

1. Pregnant woman (before or during the study).

2. Comorbidity of other neurological and/or psychiatric disorders such as unstable
seizures, schizophrenia, schizoaffective disorder, bipolar disorders or history of
substance abuse.

3. Psychotropic medication use

4. Subjects with active cardiovascular disease that is not controlled by medication.

5. Oxytocin, antibiotic, or probiotic use within the last 30 days.

6. Regular nasal obstruction or nosebleeds

7. Significant hearing, vision, or motor impairments

8. Habitual consumption of large volumes of water

9. Started taking new medications within the last 2 weeks