Probiotic and Oxytocin Combination Therapy in Patients with Autism Spectrum Disorder: A Randomized, Double-Blinded, Placebo-Controlled Pilot Trial
Open accessAbstract
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.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
A randomized, double-blind, placebo-controlled pilot trial of Lactobacillus plantarum PS128 and oxytocin in 35 individuals with ASD aged 3-20 years over 28 weeks demonstrated significant improvements in Social Responsiveness Scale, Aberrant Behavior Checklist, and Clinical Global Impression scores compared to placebo (p < 0.05).
“A randomized, double-blind, placebo-controlled pilot trial evaluated the combined effects of Lactobacillus plantarum PS128 (6 × 1010 CFUs) and oxytocin in 35 individuals with ASD, aged 3–20 years, over 28 weeks. Participants were administered either probiotics or a placebo for 16 weeks, followed by oxytocin for all groups during weeks 16 to 28. The combination therapy demonstrated significant im”
From The Gut–Brain–Microbiota Connection and Its Role in Autism Spectrum Disorders (2025) · cites this paper as [128]
In the Lactobacillus plantarum PS128 and oxytocin trial, enhanced gut microbiome hubs, particularly the Eubacterium hallii group, were positively correlated with improved social cognition.
“Moreover, enhanced gut microbiome hubs, particularly the Eubacterium hallii group, were positively correlated with improved social cognition [128].”
From The Gut–Brain–Microbiota Connection and Its Role in Autism Spectrum Disorders (2025) · cites this paper as [128]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
The citation lists haven’t been fetched yet
References 73 · Cited by 150
- Authors
- 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.
- Affiliations
- Athinoula A. Martinos Center, Massachusetts General Hospital, Charlestown, MA 02129, USA
- Harvard University (US)
- Massachusetts General Hospital (US)
- Indiana University Indianapolis (US)
- ORCID
- Venue
- Nutrients
- Publisher
- MDPI AG
- Published
- 2021-05-05
- Volume
- 13
- Issue
- 5
- Pages
- 1552
- ISSN
- 2072-6643 (ISSN-L)
- PMC
- PMC8147925
- OpenAlex
- W3158776535
- Cited by
- 150
- References
- 73
- Citations by year
- 2026: 21 · 2025: 31 · 2024: 39 · 2023: 23 · 2022: 31 · 2021: 5
- FWCI
- 12.89
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Nutrients (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- IUScholarWorks (Indiana University) (submittedVersion, cc-by)
- Funders
- Massachusetts General Hospital (#230361, #233263)
- Topics
- Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- autism spectrum disorder, probiotics, oxytocin, combination therapy, gut microbiota, social cognition, aberrant behavior, Eubacterium hallii, inflammatory markers, social responsiveness
- MeSH terms
- Autism Spectrum Disorder, Eubacteriales, Gastrointestinal Microbiome, Social Cognition, Adolescent, Child, Child, Preschool, Combined Modality Therapy, Double-Blind Method, Feces, Female, Humans, Male, Oxytocin, Pilot Projects, Biomarkers, Treatment Outcome, Inflammation Mediators, Probiotics, Lactiplantibacillus plantarum, Young Adult
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
