Probiotic and Oxytocin Combination Therapy in Patients with Autism Spectrum Disorder: A Randomized, Double-Blinded, Placebo-Controlled Pilot Trial

What Was Tested

The paper reports a study of Oxytocin, published as a randomized controlled trial.

Autism spectrum disorder (ASD) is a rapidly growing neurodevelopmental disorder.

The researchers conducted a randomized, double-blinded, placebo-controlled, 2-stage pilot trial in 35 individuals with ASD aged 3-20 years (median = 10.30 years).

Who Took Part

The study group was 35 individuals.

PubMed indexes the participants as young children, children, teenagers and young adults, both men and women.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and pilot study.

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.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Oxytocin could be set against what happens without it.

It is described as a pilot, a small early test of whether a larger Oxytocin study would be practical.

A time span of 28 weeks appears in the methods.

What Was Measured

The primary outcomes measure socio-behavioral severity using the Social Responsiveness Scale (SRS) and Aberrant Behavior Checklist (ABC).

The secondary outcomes include measures of the Clinical Global Impression (CGI) scale, fecal microbiome, blood serum inflammatory markers, and oxytocin.

The subject headings attached to it are Autism Spectrum Disorder, Biomarkers, Eubacteriales, Combined Modality Therapy, Feces, Gastrointestinal Microbiome and Inflammation Mediators.

Author keywords: autism spectrum disorder (ASD), inflammation markers, oxytocin and probiotics.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Oxytocin in 35 individuals over 28 weeks.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2021 (Nutrients), a journal based in Switzerland.

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