Related Experiment Video
Updated: Dec 28, 2025
A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research
Published on: July 31, 2017
Probiotics and oxytocin nasal spray as neuro-social-behavioral interventions for patients with autism spectrum
Xue-Jun Kong1,2, Jun Liu1,3, Jing Li4
11Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, 149 13th Street, Charlestown, MA USA.
Insights
This pilot study investigates the feasibility of using Lactobacillus reuteri (L. reuteri) probiotics and oxytocin (OXT) nasal spray to improve social behaviors in autism spectrum disorder (ASD). Preliminary data will inform larger trials on these interventions for ASD.
Area of Science:
- Neuroscience
- Gastroenterology
- Psychiatry
Background:
- Autism spectrum disorder (ASD) involves social and communication impairments.
- Oxytocin (OXT) influences social behaviors; Lactobacillus reuteri (L. reuteri) shows promise in animal models.
- Efficacy of L. reuteri and OXT in ASD patients requires further investigation.
Purpose of the Study:
- To evaluate the feasibility of a randomized controlled trial for L. reuteri probiotics and OXT in ASD patients.
- To assess the preliminary efficacy of these interventions on social and behavioral functions.
- To inform the design of a larger, fully powered clinical trial.
Main Methods:
- A two-stage, randomized, double-blind, placebo-controlled pilot study with 60 ASD patients.
- Interventions include oral L. reuteri or placebo, followed by intranasal OXT spray.
- Primary outcomes: serum OXT levels, social behaviors (questionnaires, facial matching, eye-tracking). Secondary outcomes: GI function, gut microbiome.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- The pilot study will assess feasibility aspects like recruitment, adherence, and tolerability.
- It will provide preliminary efficacy data for L. reuteri and OXT in ASD.
- Successful completion will guide a larger, definitive randomized controlled trial.
Background:
Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder characterized by impairments in social interaction and communication. Oxytocin (OXT), as a neuropeptide, plays a role in emotional and social behaviors. Lactobacillus reuteri (L. reuteri) supplementation led to an OXT-dependent behavioral improvement in ASD mouse models. Despite some promising results from animal studies, little is known about the efficacy of supplementation with L. reuteri, alone or with exogenous OXT therapy, on social-behavioral functions in ASD patients. This paper presents a protocol for a pilot randomized controlled trial to evaluate the feasibility of conducting a full trial comparing oral supplementation of L. reuteri probiotics and intranasal OXT spray to placebo on the effect of social and behavioral functions in ASD patients. The study will also capture preliminary estimates of the efficacy of the proposed interventions in ASD patients.
Methods:
This pilot trial is a two-staged, randomized, double-blind, placebo-controlled, parallel-group study. Throughout the study (0-24 weeks), 60 patients with ASD will be randomly assigned to receive either oral L. reuteri probiotics or placebo. In the second study stage (13-24 weeks), all participants will receive intranasal OXT spray. As primary outcomes, serum OXT levels will be assayed and social behaviors will be assessed via the Autism Behavior Checklist and the Social Responsiveness Scale which are validated questionnaires, an objective emotional facial matching test, and a new video-based eye-tracking test. Secondary outcomes include the GI-severity-index and Bristol Stool Chart to assess GI function and gut microbiome/short-chain fatty acids. All the outcomes will be assessed at baseline and weeks 12 and 24.
Discussion:
This pilot study will provide important information on the feasibility of recruitment, blinding and concealment, treatment administration, tolerability and adherence, specimen collection, outcome assessment, potential adverse effects, and the preliminary efficacy on both primary and secondary outcomes. If successful, this pilot study will inform a larger randomized controlled trial fully powered to examine the efficacies of oral L. reuteri probiotics and/or intranasal OXT spray on social-behavioral improvement in ASD patients.
Trial Registration:
ClinicalTrials.gov, NCT03337035. Registered 8 November 2017.
Related Concept Videos
01:19Autism Spectrum Disorder
These core symptoms manifest differently among individuals, ranging from mild to severe. The disorder's complexity extends beyond its clinical presentation, encompassing a diverse range of biological, cognitive, and sociocultural influences.
01:24Operant Conditioning Intervention
In operant conditioning, behaviors that are...