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Study · Not a test of the peptide alone · 2021

5 results

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

Kong XJ, Liu J, Liu K, Koh M, Sherman H, Liu S, Tian R, Sukijthamapan P, Wang J, Fong M, Xu L, Clairmont C and 10 more

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Jeong MS, Li A, Lopes M, Hagan V, Dutton T, Chan SP, Lee H, Kendall A, Kwong K, Song Y

Nutrients5 May 2021Cited by 90 (Europe PMC)

PMID34062986 (opens in a new tab)PMCIDPMC8147925 (opens in a new tab)DOI10.3390/nu13051552 (opens in a new tab)PepBankPUB-34062986
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Summary

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.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone5

In this study, Oxytocin was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Oxytocin.

  1. 01HumanNot a test of Oxytocin aloneRandomized controlled trialEfficacy outcome

    In individuals with ASD, the combination of a probiotic and oxytocin improved ABC scores versus placebo (p < 0.05).

    In plain wordsIn people with autism, a probiotic and oxytocin combination improved behavior checklist scores compared with placebo.

    Peptide
    Oxytocin
    Outcome
    DecreaseAberrant Behavior Checklist (ABC) score
    Study

    n = 35

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Autism core symptoms · Mental health and mood

    Source sentences

    Summary
    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).
    3 context sentences
    Summary · context
    The primary outcomes measure socio-behavioral severity using the Social Responsiveness Scale (SRS) and Aberrant Behavior Checklist (ABC).
    Summary · context
    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).
    Summary · context
    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.

    In this study, Oxytocin was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Oxytocin.

  2. 02HumanNot a test of Oxytocin aloneRandomized controlled trialEfficacy outcome

    In individuals with ASD, the combination of a probiotic and oxytocin improved SRS scores versus placebo (p < 0.05).

    In plain wordsIn people with autism, a probiotic and oxytocin combination improved social responsiveness scores compared with placebo.

    Peptide
    Oxytocin
    Outcome
    DecreaseSocial Responsiveness Scale (SRS) score
    Study

    n = 35

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Autism core symptoms · Mental health and mood

    Source sentences

    Summary
    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).
    3 context sentences
    Summary · context
    The primary outcomes measure socio-behavioral severity using the Social Responsiveness Scale (SRS) and Aberrant Behavior Checklist (ABC).
    Summary · context
    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).
    Summary · context
    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.

    In this study, Oxytocin was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Oxytocin.

  3. 03HumanNot a test of Oxytocin aloneRandomized controlled trialEfficacy outcome

    In individuals with ASD, the combination of a probiotic and oxytocin gave significant improvements in CGI-improvement versus placebo (p < 0.05).

    In plain wordsIn people with autism, a probiotic and oxytocin combination gave better clinician-rated improvement than placebo.

    Peptide
    Oxytocin
    Outcome
    Direction not reportedClinical Global Impression-improvement (CGI-I)
    Study

    n = 35

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Anxiety and mood · Mental health and mood

    Source sentences

    Summary
    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).
    3 context sentences
    Summary · context
    The secondary outcomes include measures of the Clinical Global Impression (CGI) scale, fecal microbiome, blood serum inflammatory markers, and oxytocin.
    Summary · context
    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).
    Summary · context
    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.

    In this study, Oxytocin was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Oxytocin.

  4. 04HumanNot a test of Oxytocin aloneRandomized controlled trialMechanism

    In individuals with ASD, a significant number of favorable gut microbiome network hubs were identified after probiotic and oxytocin combination therapy (p < 0.05).

    In plain wordsIn people with autism, a probiotic and oxytocin combination was followed by more favorable gut microbiome network hubs.

    Peptide
    Oxytocin
    Outcome
    Direction not reportedGut microbiome network hubs
    Study

    n = 35

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Immune response · Immune and inflammation

    Source sentences

    Summary
    A significant number of favorable gut microbiome network hubs were also identified after combination therapy (p < 0.05).
    3 context sentences
    Summary · context
    The secondary outcomes include measures of the Clinical Global Impression (CGI) scale, fecal microbiome, blood serum inflammatory markers, and oxytocin.
    Summary · context
    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).
    Summary · context
    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.

    In this study, Oxytocin was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Oxytocin.

  5. 05HumanNot a test of Oxytocin aloneRandomized controlled trialMechanism

    In individuals with ASD, the favorable social cognition response to the combination regimen was highly correlated with the abundance of the Eubacterium hallii group.

    In plain wordsIn people with autism, the better social response to the combination was linked to more Eubacterium hallii gut bacteria.

    Peptide
    Oxytocin
    Outcome
    Not applicableSocial cognition response and Eubacterium hallii group abundance
    Study

    n = 35

    Comparator
    Placebo
    Outcome group
    Social behavior and cognition · Mental health and mood

    Source sentences

    Summary
    The favorable social cognition response of the combination regimen is highly correlated with the abundance of the Eubacterium hallii group.
    2 context sentences
    Summary · context
    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).
    Summary · context
    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.

    In this study, Oxytocin was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Oxytocin.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    11 Oct 2026, 00:50 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 02:48 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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