Clinical Trial Protocol: Testing Probiotics Plus Oxytocin for Autism Social Deficits
Two-stage pilot RCT protocol testing L. reuteri probiotics (12 weeks) followed by added oxytocin nasal spray (12 more weeks) for social deficits in 60 ASD patients.
Quick Facts
What This Study Found
This is a protocol for a two-stage pilot randomized controlled trial. In stage one (weeks 0-12), 60 ASD patients receive either oral L. reuteri probiotics or placebo. In stage two (weeks 13-24), all participants also receive intranasal oxytocin spray.
Primary outcomes include serum oxytocin levels, social behavior scores (Autism Behavior Checklist, Social Responsiveness Scale), an emotional facial matching test, and eye-tracking. Secondary outcomes include GI function, gut microbiome composition, and short-chain fatty acid levels.
The rationale is based on animal studies showing L. reuteri increases oxytocin levels and improves social behavior in ASD mouse models. Intranasal oxytocin has shown some promise in improving social functioning in ASD patients.
Key Numbers
60 participants; 24 weeks; 2-stage design; probiotics for 24 weeks, oxytocin added at week 13
How They Did This
This is a trial protocol, not a results paper. The design is a two-stage, randomized, double-blind, placebo-controlled, parallel-group pilot study. Sixty participants with ASD will be enrolled. Outcomes are assessed at baseline, week 12, and week 24.
Why This Research Matters
Autism spectrum disorder has no FDA-approved treatments targeting core social deficits. Both oxytocin and gut-brain interventions are promising but understudied. This trial is innovative because it tests whether a probiotic can boost the body's own oxytocin production and whether combining it with intranasal oxytocin produces additive benefits.
The gut-brain-behavior connection in autism is a rapidly growing research area.
The Bigger Picture
Autism has no approved treatment for core social deficits. Both oxytocin and gut-brain interventions show promise individually. This trial innovatively tests whether probiotics can boost oxytocin levels naturally and enhance the effect of exogenous oxytocin.
What This Study Doesn't Tell Us
This is a protocol paper, not a results paper. The trial had not yet reported outcomes at the time of publication. As a pilot study with 60 participants, it is designed to test feasibility rather than prove efficacy.
The two-stage design means the probiotic effect cannot be fully separated from the oxytocin effect in the second stage.
Questions This Raises
- ?Do L. reuteri probiotics actually increase serum oxytocin levels in ASD patients?
- ?Will the two-stage design distinguish probiotic effects from oxytocin effects?
- ?Is 60 participants enough to detect meaningful social improvements?
Trust & Context
- Key Stat:
- 60 patients, 24 weeks pilot trial testing whether probiotics can enhance oxytocin therapy for autism social deficits through the gut-brain axis
- Evidence Grade:
- Not applicable — this is a protocol paper, not a results paper. The trial design is sound but outcomes have not been reported.
- Study Age:
- Published in 2020. Trial results may have been published since.
- Original Title:
- Probiotics and oxytocin nasal spray as neuro-social-behavioral interventions for patients with autism spectrum disorders: a pilot randomized controlled trial protocol.
- Published In:
- Pilot and feasibility studies, 6, 20 (2020)
- Authors:
- Kong, Xue-Jun, Liu, Jun(5), Li, Jing(15), Kwong, Kenneth, Koh, Madelyn, Sukijthamapan, Piyawat, Guo, Jason J, Sun, Zhenyu Jim, Song, Yiqing
- Database ID:
- RPEP-04913
Evidence Hierarchy
Frequently Asked Questions
Could probiotics help with autism?
Some research suggests gut bacteria influence brain function through the gut-brain axis. L. reuteri specifically may boost oxytocin, a hormone involved in social behavior. This trial tests whether this connection can improve social function in autism.
When will results be available?
This is a protocol paper from 2020. Results from the actual trial may have been published since. Check for updates from the research team.
Read More on RethinkPeptides
Cite This Study
https://rethinkpeptides.com/research/RPEP-04913APA
Kong, Xue-Jun; Liu, Jun; Li, Jing; Kwong, Kenneth; Koh, Madelyn; Sukijthamapan, Piyawat; Guo, Jason J; Sun, Zhenyu Jim; Song, Yiqing. (2020). Probiotics and oxytocin nasal spray as neuro-social-behavioral interventions for patients with autism spectrum disorders: a pilot randomized controlled trial protocol.. Pilot and feasibility studies, 6, 20. https://doi.org/10.1186/s40814-020-0557-8
MLA
Kong, Xue-Jun, et al. "Probiotics and oxytocin nasal spray as neuro-social-behavioral interventions for patients with autism spectrum disorders: a pilot randomized controlled trial protocol.." Pilot and feasibility studies, 2020. https://doi.org/10.1186/s40814-020-0557-8
RethinkPeptides
RethinkPeptides Research Database. "Probiotics and oxytocin nasal spray as neuro-social-behavior..." RPEP-04913. Retrieved from https://rethinkpeptides.com/research/kong-2020-probiotics-and-oxytocin-nasal
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkPeptides research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.