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Probiotics for Gastrointestinal Symptoms and Quality of Life in Autism: A Placebo-Controlled Pilot Trial.
- Source :
-
Journal of child and adolescent psychopharmacology [J Child Adolesc Psychopharmacol] 2019 Nov; Vol. 29 (9), pp. 659-669. Date of Electronic Publication: 2019 Aug 30. - Publication Year :
- 2019
-
Abstract
- 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.
Details
- Language :
- English
- ISSN :
- 1557-8992
- Volume :
- 29
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Journal of child and adolescent psychopharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 31478755
- Full Text :
- https://doi.org/10.1089/cap.2018.0156