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Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT) — SPROUT  

Autism Spectrum Disorder Clinical Trial

Official title:
A Randomized Double-Blind Placebo Controlled Cross-Over Study of CP101 (Full-Spectrum Microbiota®) in Children With Autism Spectrum Disorder and Associated Gastrointestinal Symptoms

Clinical Trial Summary

Adolescent autism spectrum disorder subjects with associated GI symptoms will be randomized to receive oral dosing of CP101 capsules in Treatment Group I or matching placebo capsules in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 in subjects with ASD and associated GI symptoms.

Clinical Trial Description

This is a Randomized Double-Blind Placebo Controlled Study of CP101 (Full-Spectrum Microbiota®) in Children with Autism Spectrum Disorder and Associated Gastrointestinal Symptoms ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03829878
Study type Interventional
Source Finch Research and Development LLC.
Contact
Status Withdrawn
Phase Phase 2
Start date May 2020
Completion date December 2021
View Details
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