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

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Athinoula A. Martinos Center, Massachusetts General Hospital, Charlestown, MA 02129, USA
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Department of Psychiatry, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA
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Harvard Medical School, Boston, MA 02115, USA
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Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA 02114, USA
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MGH Biostatistics Center, Massachusetts General Hospital, Boston, MA 02114, USA
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Department of Epidemiology, Indiana University, Richard M. Fairbanks School of Public Health, Indianapolis, IN 46202, USA
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Author to whom correspondence should be addressed.
Nutrients 2021, 13(5), 1552; https://doi.org/10.3390/nu13051552
Received: 9 April 2021 / Revised: 1 May 2021 / Accepted: 2 May 2021 / Published: 5 May 2021
(This article belongs to the Section Prebiotics and Probiotics)
Autism spectrum disorder (ASD) is a rapidly growing neurodevelopmental disorder. Both probiotics and oxytocin were reported to have therapeutic potential; however, the combination therapy has not yet been studied. We conducted a randomized, double-blinded, placebo-controlled, 2-stage pilot trial in 35 individuals with ASD aged 3–20 years (median = 10.30 years). Subjects were randomly assigned to receive daily Lactobacillus plantarum PS128 probiotic (6 × 1010 CFUs) or a placebo for 28 weeks; starting on week 16, both groups received oxytocin. 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. All outcomes were compared between the two groups at baseline, 16 weeks, and 28 weeks into treatment. We observed improvements in ABC and SRS scores and significant improvements in CGI-improvement between those receiving probiotics and oxytocin combination therapy compared to those receiving placebo (p < 0.05). A significant number of favorable gut microbiome network hubs were also identified after combination therapy (p < 0.05). The favorable social cognition response of the combination regimen is highly correlated with the abundance of the Eubacterium hallii group. Our findings suggest synergic effects between probiotics PS128 and oxytocin in ASD patients, although further investigation is warranted. View Full-Text
Keywords: autism spectrum disorder (ASD); probiotics; oxytocin; microbiome; inflammation markers autism spectrum disorder (ASD); probiotics; oxytocin; microbiome; inflammation markers
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MDPI and ACS Style

Kong, X.-J.; Liu, J.; Liu, K.; Koh, M.; Sherman, H.; Liu, S.; Tian, R.; Sukijthamapan, P.; Wang, J.; Fong, M.; Xu, L.; Clairmont, C.; Jeong, M.-S.; Li, A.; Lopes, M.; Hagan, V.; Dutton, T.; Chan, S.-T.; Lee, H.; Kendall, A.; Kwong, K.; Song, Y. Probiotic and Oxytocin Combination Therapy in Patients with Autism Spectrum Disorder: A Randomized, Double-Blinded, Placebo-Controlled Pilot Trial. Nutrients 2021, 13, 1552. https://doi.org/10.3390/nu13051552

AMA Style

Kong X-J, Liu J, Liu K, Koh M, Sherman H, Liu S, Tian R, Sukijthamapan P, Wang J, Fong M, Xu L, Clairmont C, Jeong M-S, Li A, Lopes M, Hagan V, Dutton T, Chan S-T, Lee H, Kendall A, Kwong K, Song Y. Probiotic and Oxytocin Combination Therapy in Patients with Autism Spectrum Disorder: A Randomized, Double-Blinded, Placebo-Controlled Pilot Trial. Nutrients. 2021; 13(5):1552. https://doi.org/10.3390/nu13051552

Chicago/Turabian Style

Kong, Xue-Jun, Jun Liu, Kevin Liu, Madelyn Koh, Hannah Sherman, Siyu Liu, Ruiyi Tian, Piyawat Sukijthamapan, Jiuju Wang, Michelle Fong, Lei Xu, Cullen Clairmont, Min-Seo Jeong, Alice Li, Maria Lopes, Veronica Hagan, Tess Dutton, Suk-Tak Chan, Hang Lee, Amy Kendall, Kenneth Kwong, and Yiqing Song. 2021. "Probiotic and Oxytocin Combination Therapy in Patients with Autism Spectrum Disorder: A Randomized, Double-Blinded, Placebo-Controlled Pilot Trial" Nutrients 13, no. 5: 1552. https://doi.org/10.3390/nu13051552

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