Clinical Trials Logo
  1. Home
  2. Autistic Disorder
  3. NCT04944901

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

Autistic Disorder Clinical Trial

Official 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

Clinical Trial Summary

SB-121 is being developed for use in the treatment of autistic disorder (AD). This study is a multiple-dose, randomized, double-blind, placebo-controlled, cross-over single-site Phase I study. The primary objective is to evaluate the safety and tolerability of multiple doses of SB-121 in subjects ages 15 to 45 years with AD. Additionally, multiple measures of AD, as well as mechanistic biomarkers, will be assessed in order to inform later stage trials.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04944901
Study type Interventional
Source Scioto Biosciences, Inc.
Contact
Status Completed
Phase Phase 1
Start date August 2, 2021
Completion date March 3, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03222375 - SQUED™ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism N/A
Completed NCT02568631 - Improving Social Cognition for Adults With ASD by the Serious Game JeStiMulE Versus Controls N/A
Completed NCT02708290 - Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Completed NCT02369445 - Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention N/A
Completed NCT01592747 - Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine Phase 2
Completed NCT01617460 - A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder Phase 3
Completed NCT01400269 - An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism N/A
Active, not recruiting NCT02442115 - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Completed NCT00926471 - Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum Disorders Phase 1
Completed NCT00365859 - Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD) Phase 3
Completed NCT00692315 - Treating Oxidative Stress in Children With Autism N/A
Completed NCT00198107 - Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism Phase 3
Completed NCT00095420 - Relationship Training for Children With Autism and Their Peers N/A
Completed NCT00027404 - Study of Fluoxetine in Adults With Autistic Disorder N/A
Recruiting NCT05910502 - Project AFECT (Autism Family Empowerment Coaching and Training Program) N/A
Completed NCT04820998 - Living in a Precarious Situation With an Autistic Child: What Are the Issues at Stake for Support in Care
Withdrawn NCT05413187 - A Trial to Assess the Efficacy and Safety of Medical Grade Cannabis in Children Diagnosed With Autism Spectrum Disorder Phase 2
Recruiting NCT02275455 - Design Of WELL Being Monitoring Systems, Application in Autism N/A
Completed NCT02766101 - Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges N/A
Completed NCT01977248 - Sensorimotor Affect Relationship-based Therapy (SMART) for Children With Autism Spectrum Disorders Ages 2-12 N/A