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NCT03337035 · ClinicalTrials.gov registry record · Phase 1
Probiotics and Oxytocin Nasal Spray on Social Behaviors of Autism Spectrum Disorder (ASD) Children
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT03337035: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT03337035 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03337035, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study 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.
Primary Outcome
social communication and behavior - The scoring is based on T-score which is based on the sum of responses as follows (76 to higher - severe, 66 to 75- moderate deficiencies, 60 to 65 - mild deficiencies, 59 and below is not clinically significant for ASD).
Interventions
- DRUG intranasal oxytocin
- DIETARY_SUPPLEMENT oral probiotics
- DIETARY_SUPPLEMENT oral placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-12-01 |
| Est. Completion | 2019-10-02 |
| Phase | Phase 1 |
What the finished NCT03337035 record still lists
NCT03337035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 3 interventions - of which intranasal oxytocin is the first listed.
NCT03337035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03337035 about?
NCT03337035 is a clinical study titled "Probiotics and Oxytocin Nasal Spray on Social Behaviors of Autism Spectrum Disorder (ASD) Children". 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 inves...
What is the current status of trial NCT03337035?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2018-12-01. Estimated completion is 2019-10-02.
What interventions are being tested in trial NCT03337035?
The interventions under investigation include: intranasal oxytocin (DRUG), oral probiotics (DIETARY_SUPPLEMENT), oral placebo (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03337035?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03337035's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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