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- W3126367028 abstract "Abstract 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. Animal studies showed that Lactobacillus reuteri (L. reuteri) supplementation led to an OXT-dependent behavioral improvement in ASD mouse models. We thus designed the first clinical trial to test whether supplementation with L. reuteri would improve social behavioral functions in ASD patients; whether there is a synergy between probiotics treatment and exogenous OXT therapy; and whether such OXT pathway-targeted therapies alter the gut-brain axis, including autonomic function, gastrointestinal (GI) health, gut microbial profiles, gut/brain inflammation, and brain activity. Methods/design: This clinical trial is a two-staged, randomized, double-blind, placebo-controlled, parallel-group study. Throughout the study (0-24 weeks), 60 ASD patients will be randomly assigned to receive either oral L. reuteri probiotics or placebo. In the 2nd stage (13-24 weeks) of the study, all participants will also receive intranasal OXT spray. As primary outcomes, serum OXT levels will be assayed and social behaviors will be measured via two validated questionnaires, an objective emotional facial matching test, and a new video-based eye tracking test. Secondary outcomes include autonomic function indices, GI function, gut microbiome/short chain fatty acids, brain activity in social response regions via functional magnetic resonance imaging (fMRI), and serum neuroinflammatory/neurotransmitter/neuro-injury biomarkers. All the outcomes will be assessed at baseline, week 12, and week 24. Discussion: This pilot study will provide important empirical data to evaluate potential effects of oral probiotics in improving ASD core symptoms through modulating endogenous OXT, examine the synergistic effects between probiotics and exogenous OXT treatment, and further explore the relationship of OXT with the gut-brain axis in ASD patients. Trial registration : ClinicalTrial.gov, NCT03337035. Registered 8 November 2017, https://clinicaltrials.gov/ct2/show/NCT03337035 Keywords: Autism spectrum disorders; Intranasal; Oxytocin; Probiotics" @default.
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- W3126367028 date "2019-01-31" @default.
- W3126367028 modified "2023-09-26" @default.
- W3126367028 title "The effects of probiotics and oxytocin nasal spray on neuro-social behaviors of children with Autism Spectrum Disorders (ASD): study protocol for a randomized, double-blinded, placebo-controlled, parallel-group clinical trial" @default.
- W3126367028 doi "https://doi.org/10.21203/rs.2.260/v1" @default.
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