Compositions and methods for treating autism spectrum disorders

Abstract

The present disclosure relates to compositions and methods for treating autism spectrum disorder (ASD). Provided herein are pharmaceutical compositions and formulations comprising an uncultured fecal bacterial product derived from fecal of a human donor and at least one, at least two or all three non-pathogenic microbial types selected from the group consisting of bacterial isolates, fungal isolates, and archaea isolates (e.g., bacterial isolates comprising Lactobacillus reuteri), and methods of treating ASD patients with the compositions. Further provided is a method of preparing a pharmaceutical composition comprising Lactobacillus reuteri.

Description

Cross References to Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 950,805, filed December 19, 2019, and U.S. Provisional Application No. 62 / 899,874, filed September 13, 2019, which are hereby incorporated by reference in their entirety. Background technique Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder characterized by widespread social and communication abnormalities, as well as restricted interests and repetitive behaviors. ASD typically presents in the first three years of life and manifests as characteristic symptoms or behavioral traits. The diagnosis of ASD now includes several conditions that were previously diagnosed separately: autism, combined developmental disorder not otherwise specified (PDD-NOS), and Asperger syndrome. All of these conditions are now covered by the diagnostic criteria for autism spectrum disorder specified in the American Psychiatric Association's Diagnostic & Statisti...

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Problems solved by technology

In addition, potential differences in the following could lead to uncertainty in the efficacy of fecal bacterial therapy in groups of patients with or predisposed to the disorder: (i) the identity and relative abundance of specific bacterial strains in different donor samples; and (ii) The degree of engraftment of specific bacterial strains in the gut of recipients of bacteriotherapy

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