Randomized, Double-blind, Placebo-controlled, 28-Day Daily-dose Crossover Study of the Safety and Tolerability of SB-121 (Lactobacillus Reuteri With Sephadex® and Maltose) in Subjects, Ages 15 to 45 Years, Diagnosed With Autistic Disorder
Phase: PHASE1
Conditions: Autistic Disorder
Sponsor: Scioto Biosciences, Inc.

Document Type: 
Final Protocol 
Document Date:  
Version 4 – 15 October 2021 
Study Title:  
Randomized, Double-blind, Placebo-controlled, 28-Day Daily-dose 
Crossover Study of the Safety and Tolerability of SB-121 
(Lactobacillus reuteri with Sephadex® and Maltose) in Subjects, ages 
15 to 45 years, diagnosed with Autistic Disorder 
Protocol Reference Number:  SBI-SB121-20-01 
NCT Number:  
NCT04944901