Evidence map›Paper›PMID 32082606›Full record

ArticlePilot and feasibility studies2020

Probiotics and oxytocin nasal spray as neuro-social-behavioral interventions for patients with autism spectrum disorders: a pilot randomized controlled trial protocol.

Xue-Jun Kong, Jun Liu, Jing Li, Kenneth Kwong, Madelyn Koh, Piyawat Sukijthamapan, Jason J Guo, Zhenyu Jim Sun, Yiqing Song

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03337035 (The Effects of Probiotics and Oxytocin Nasal Spray on Social Behaviors of ASD Children- A Pilot Study), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
6.0field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03337035 phase1completednot on this map

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

TypeinterventionalSponsorMassachusetts General HospitalRan2018 to 2019Enrolled35ConditionsAutism Spectrum DisorderArmsintranasal oxytocin, oral probiotics, oral placebo
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. Microorganisms · 2022
    Review
  11. Next-Generation Probiotic Therapy to Protect the Intestines From Injury.Frontiers in cellular and infection microbiology · 2022
    Review
  12. Article
  13. Review
  14. Review
  15. The Possible Role ofOxidative medicine and cellular longevity · 2021
    Article
  16. Review
  17. Review
  18. Review
  19. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 2 countries.

Xue-Jun Kong1Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, 149 13th Street, Charlestown, MA USA.ORCID 0000-0001-8551-8877
Jun Liu1Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, 149 13th Street, Charlestown, MA USA.
Jing Li4Department of Biostatistics, Richard M. Fairbanks School of Public Health, Indiana University, Indianapolis, IN USA.
Kenneth Kwong1Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, 149 13th Street, Charlestown, MA USA.
Madelyn Koh1Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, 149 13th Street, Charlestown, MA USA.
Piyawat Sukijthamapan3Harvard Medical School, Boston, MA USA.
Jason J Guo5Barnett Institute for Chemical and Biological Analysis, Department of Chemistry and Chemical Biology, Northeastern University, Boston, MA USA.
Zhenyu Jim Sun6Dana Farber Cancer Institute, Harvard Medical School, Boston, MA USA.
Yiqing Song7Department of Epidemiology, Richard M. Fairbanks School of Public Health, Indiana University, Indianapolis, IN USA.
Massachusetts General Hospital · USBoston Medical Center · USRichard M. Fairbanks Foundation · USHarvard University · USNortheastern University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAutism 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.

methodsThis pilot trial is a two-staged, randomized, double-blind, placebo-controlled, parallel-group study. Throughout the study (0-24 weeks), 60 patients with ASD will be randomly assigned to receive either oral DISCUSSION: This pilot study will provide important information on the feasibility of recruitment, blinding and concealment, treatment administration, tolerability and adherence, specimen collection, outcome assessment, potential adverse effects, and the preliminary efficacy on both primary and secondary outcomes. If successful, this pilot study will inform a larger randomized controlled trial fully powered to examine the efficacies of oral

trial registrationClinicalTrials.gov, NCT03337035. Registered 8 November 2017.

Indexed as

ASDAutism spectrum disordersNeuro-social behaviorsOXTOxytocinProbioticsRandomized controlled trial

Identifiers

PMID32082606
PMCPMC7017510
OpenAlexW3011506894

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.