Probiotics for gastrointestinal symptoms and quality of life in autism: a placebo-controlled pilot trial
Open accessAbstract
Objective: A randomized pilot trial of gastrointestinal (GI) symptoms targeting probiotic for quality of life in autism spectrum disorder (ASD). Methods: Thirteen children, 3–12 years of age with ASD, anxiety, and GI symptoms, were randomized into a probiotic crossover trial of 8 weeks each on VISBIOME and placebo separated by a 3-week washout. VISBIOME contains eight probiotic species, mostly Lactobacillus and Bifidobacterium. Primary outcome was the Pediatric Quality of Life Inventory (PedsQL) GI module. Secondary outcomes included gut microbiota analysis, the Parent-Rated Anxiety Scale for ASD (PRAS-ASD), and parent-selected target symptoms. A mixed analysis model was applied. Results: Thirteen children were randomized, with 10 completing the study (77% retention): 6 in probiotic/placebo sequence, 4 in placebo/probiotic sequence. Adherence to study treatment was 96%. There were no serious adverse events (AEs), and more nonserious AEs occurred with placebo than with probiotic, including those attributable to treatment. Only 6 of the 10 guessed the correct treatment at the end of week 8. Over the 19-week trial, each outcome improved from baseline and PedsQL correlated significantly with abundance of Lactobacillus without discernable changes to microbiota composition/diversity. Although probiotic showed more improvement than placebo, PedsQL and PRAS-ASD were not statistically significant, as expected at this sample size. PedsQL effect size was d = 0.49 by the general model and d = 0.79 by simple comparison of week 8 changes. A parent-selected target symptom showed significant improvement in GI complaints on probiotic compared with placebo (p = 0.02, d = 0.79). Probiotic effects carried over through the 3-week washout. Conclusion: The VISBIOME formulation was safe and suggested a health benefit in children with ASD and GI symptoms who retained Lactobacillus. The moderate effect size compared with placebo warrants a larger trial using a parallel-group design.
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Anecdotal reports of behavioral improvements following effective treatment for GI problems exist, but prospective studies are still required.
“Although there are anecdotal reports of behavioral improvements following effective treatment for GI problems, prospective studies are still required 7475.”
From Gastrointestinal Issues and Autism Spectrum Disorder (2020) · cites this paper as [74]
In a small-randomized pilot trial of probiotics in children with ASD and GI problems, a probiotic mixture of eight Lactobacillus and Bifidobacterium species was given for the 19-week trial period.
“Recently, a small-randomized pilot trial of probiotics in children with ASD and GI problems was conducted. A probiotic mixture of eight Lactobacillus and Bifidobacterium species was given for the 19-week trial period.”
From Gastrointestinal Issues and Autism Spectrum Disorder (2020) · cites this paper as [74]
In that trial, parents reported a significant improvement in GI symptoms, but the overall resulting quality of life measures were not significant.
“Although parents reported a significant improvement in GI symptoms, the overall resulting quality of life measures were not significant 74.”
From Gastrointestinal Issues and Autism Spectrum Disorder (2020) · cites this paper as [74]
Anecdotal reports suggest that effective treatment of GI disorders is important not only for attenuation of GI problems but potential improvements in associated behavioral correlates.
“These anecdotal reports, however, suggest that effective treatment of GI disorders is important not only for the attenuation of the GI problems, but potential improvements in associated behavioral correlates as well 747677.”
From Gastrointestinal Issues and Autism Spectrum Disorder (2020) · cites this paper as [74]
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- Authors
- Arnold, L. E., Luna, R. A., Williams, K., Chan, J., Parker, R. A., Wu, Q., Hollway, J. A., Jeffs, A., Lu, F., Coury, D. L., Hayes, C., & Savidge, T.
- Affiliations
- The Ohio State University (US)
- Baylor College of Medicine (US)
- Nationwide Children's Hospital (US)
- Massachusetts General Hospital (US)
- Corresponding author
- Arnold, L. Eugene
- ORCID
- Venue
- Journal of Child and Adolescent Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2019-11-01
- Volume
- 29
- Issue
- 9
- Pages
- 659-669
- ISSN
- 1044-5463 (ISSN-L)
- 1557-8992
- PMC
- PMC7364307
- OpenAlex
- W2972209545
- Cited by
- 183
- References
- 50
- Citations by year
- 2026: 21 · 2025: 34 · 2024: 26 · 2023: 27 · 2022: 45 · 2021: 14 · 2020: 15
- FWCI
- 14.27
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Child and Adolescent Psychopharmacology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Autism Speaks
- Ohio State University
- Supernus Pharmaceuticals
- Health Resources and Services Administration
- Pfizer Pharmaceuticals
- Topics
- 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
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- probiotics, autism spectrum disorder, gastrointestinal symptoms, quality of life, anxiety, Lactobacillus, Bifidobacterium, gut microbiota, pediatric patients, crossover design
- MeSH terms
- Autism Spectrum Disorder, Child, Child, Preschool, Female, Humans, Male, Pilot Projects, Placebos, Quality of Life, Probiotics
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