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

What Was Tested

This registered phase 1 trial tested Oxytocin.

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.

It had two arms (groups): oral probiotics and oxytocin spray (active comparator) and oral placebo and oxytocin spray (placebo comparator).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

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 trial is a randomized, double-blind placebo controlled study.

Subjects will be randomized to 2 groups: Phase 1: a. oral placebo, and b. oral probiotics; Phase 2: a. intranasal Oxytocin(OXT) + oral placebo, and b. intranasal OXT + oral probiotics The treatment will proceed for a total of 28 weeks.

In the first phase (16 weeks), all the patients will be randomly and proportionally divided into two groups: Group A (30 subjects) receives oral probiotics while Group B (30 subjects) receives an oral placebo.

Who Took Part

35 actual participants took part.

It was open to people of any sex aged from 3 years up to 25 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Oxytocin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2018-12-01 with completion listed for 2019-10-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Social Responsiveness Scale (SRS) Edition 2 (time frame: change from baseline at 0, 16, and 28 weeks). Aberrant Behavior Checklist (ABC) Edition 2 (time frame: change from baseline at 0, 16, and 28 weeks).

It also tracked 13 secondary outcomes, for example Neuroinflammation and Oxytocin levels, structural MRI, Functional MRI (resting state), Functional MRI (task based), Autonomic indices 1 and Autonomic indices 2.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 35 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.