Status:
COMPLETED
Probiotics and Oxytocin Nasal Spray on Social Behaviors of Autism Spectrum Disorder (ASD) Children
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-25 years
Phase:
PHASE1
Brief 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 effe...
Detailed Description
This study description is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines that are published for the evaluation of randomized controlled trials. This clinical tr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03337035
Start Date
December 1 2018
End Date
October 2 2019
Last Update
March 4 2020
Active Locations (1)
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1
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129