Probiotics and Oxytocin Trial for ASD

The Effects of Probiotics and Oxytocin Nasal Spray on Social Behaviors of ASD Patients- A Pilot Study.

MGH 2017P001667, PI: Xue-Jun Kong, MD

Animal studies have shown that probiotics can induce the release of endogenous oxytocin (OXT). While many benefits have been attributed to probiotics in reducing GI discomfort in ASD, OXT is proposed to play a role in the brain-gut connection during the administration of probiotics in an autism treatment trial. We hypothesize that probiotic-induced endogenous oxytocin could improve social behaviors in ASD individuals. If OXT is confirmed to be the missing link of the gut-brain connection and probiotics can improve the social behaviors of ASD, probiotics will be valued for its safety for ASD management and should motivate more advanced researches leading to wide acceptance and compliance from patients and their family. Our study is also to examine whether probiotics can further enhance the beneficial effects of the exogenous OXT given by intranasal spray, and its correlation with the changes in brain imaging studies such as MRI and fMRI, biomarkers and autonomic dysfunctions. This study is registered as NCT03337035 on clinicaltrial.gov.  The outcome measurements include ABC, SRS, microbiome, blood oxytocin level, inflammation markers, eye tracking, emotion recognition, autonomic index, brain MRI.

Status: finished, active for ongoing data analysis, protocol published