Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Feb;53(2):163-178.
doi: 10.1007/s10802-024-01278-7. Epub 2025 Jan 11.

Effect of Probiotics on the Symptomatology of Autism Spectrum Disorder and/or Attention Deficit/Hyperactivity Disorder in Children and Adolescents: Pilot Study

Meritxell Rojo-Marticella  1   2   3 , Victoria Arija  1   3 , Josefa Canals-Sans  4   5   6
Affiliations
Randomized Controlled Trial

Effect of Probiotics on the Symptomatology of Autism Spectrum Disorder and/or Attention Deficit/Hyperactivity Disorder in Children and Adolescents: Pilot Study

Meritxell Rojo-Marticella et al. Res Child Adolesc Psychopathol. 2025 Feb.

Abstract

The aim of this study is to investigate the impact of using probiotics with strains related to dopamine and gamma-aminobutyric acid production on clinical features of autism spectrum disorder (ASD) and/or attention deficit/hyperactivity disorder (ADHD). This randomized, controlled trial involved 38 children with ADHD and 42 children with ASD, aged 5-16 years, who received probiotics (Lactiplantibacillus plantarum and Levilactobacillus brevis 109/cfu/daily) or placebo for 12 weeks. Parent-reported symptoms were assessed using Conners' 3rd-Ed and the Social Responsiveness Scale Test, 2nd-Ed (SRS-2), and children completed the Conners Continuous Performance Test, 3rd-Ed (CPT 3) or Conners Kiddie CPT, 2nd-Ed (K-CPT 2). Executive functions, quality of life and sleep patterns were also parent-assessed. Intention-to-treat analyses, controlling for sociodemographic and nutritional covariates, revealed no significant inter-group differences in parent-reported or neuropsychological data after the probiotic intervention. However, age-stratified analyses showed improved hyperactivity-impulsivity symptoms in younger children with ASD (Cohen's d = 1.245) and ADHD (Cohen's d = 0.692). Intra-group analyses supported these findings in the aforementioned age and intervention group for both diagnoses. An improvement in impulsivity for children with ASD was also observed in the intra-group analysis of the CPT commissions scores (probiotic: p = 0.001, Cohen's d = -1.216; placebo: p = 0.013, Cohen's d = -0.721). A better comfort score (quality of life) was shown in children with ASD (probiotic: p = 0.010, Cohen's d = 0.722; placebo: p = 0.099, Cohen's d = 0.456). The probiotics used, may improve hyperactivity-impulsivity in children with ASD or/and ADHD and quality of life in children with ASD. Further research is warranted to explore probiotics as an adjunctive therapeutic intervention for NDs.Trial registration: clinicaltrials.gov Identifier: NCT05167110.

Keywords: Adolescents; Attention deficit/hyperactive disorder; Autism spectrum disorder; Children; Probiotics; Randomized controlled trials.

PubMed Disclaimer

Conflict of interest statement

Compliance with Ethical Standards. Funding: Universitat Rovira i Virgili’s Martí Franqués Grant 2020PMF-PIPF-36. Spanish Ministry of Economy and Competitiveness and the European Regional Development Fund (ERDF) under grants PSI2015-64837-P and RTI2018- 097124-B-I00. Conflict of Interest: The authors declare no conflict of interest. Ethical Approval: The study performed in accordance with the Declaration of Helsinki and the study protocol was approved by the IISPV drug research ethics committee (Ref.CEIM:030/2017). Informed Consent: All participants and their families provided written informed consent before participating in the study.

Figures

Fig. 1
Fig. 1
Flowchart of the participants in the study
See this image and copyright information in PMC

References

    1. Aarts, E., Ederveen, T. H. A., Naaijen, J., Zwiers, M. P., Boekhorst, J., Timmerman, H. M., Smeekens, S. P., Netea, M. G., Buitelaar, J. K., Franke, B., Van Hijum, S. A. F. T., & Vasquez, A. A. (2017). Gut microbiome in ADHD and its relation to neural reward anticipation. PLoS ONE,12(9), e0183509. 10.1371/JOURNAL.PONE.0183509 - PMC - PubMed
    1. Achenbach, T.M., Rescorla, L.A. (2001). Child Behavior Checklist for ages 6–18. University of Vermont, Research Center for Children, Youth & Families.
    1. Adams, J. B., Johansen, L. J., Powell, L. D., Quig, D., & Rubin, R. A. (2011). Gastrointestinal flora and gastrointestinal status in children with autism--comparisons to typical children and correlation with autism severity. BMC Gastroenterology, 11. 10.1186/1471-230X-11-22 - PMC - PubMed
    1. Amadi, C. N., Orish, C. N., Frazzoli, C., & Orisakwe, O. E. (2022). Dietary interventions for autism spectrum disorder: An updated systematic review of human studies. Psychiatrike = Psychiatriki,33(3), 228–242. 10.22365/JPSYCH.2022.073 - PubMed
    1. American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders: DSM-5 (5th ed.). American Psychiatric Publishing, Inc. 10.1176/appi.books.9780890425596

Publication types

Associated data