The Gut-Brain Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Autism Spectrum Disorder (ASD
- Gastro-Intestinal Disorder
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 5 years and 17 years
- Gender
- Both males and females
Description
Nearly 1 in 60 children are diagnosed with ASD, a dramatic increase from the start of the 21st century. Although most children with ASD exhibit core social communication deficits, very limited interests, repetitive behaviors and sensory problems, the severity of symptoms and how well each child resp...
Nearly 1 in 60 children are diagnosed with ASD, a dramatic increase from the start of the 21st century. Although most children with ASD exhibit core social communication deficits, very limited interests, repetitive behaviors and sensory problems, the severity of symptoms and how well each child responds to standard behavioral therapies can vary tremendously from patient to patient. This makes it difficult to enact effective interventions. Other variables also influence the outcomes for ASD patients, including age at first diagnosis, access to care, the quality of treatments and the expertise of interventionists. Children with ASD also have medical disturbances, which affects their quality of life and compliance in intervention programs. For example, approximately 40 percent of children with ASD have gastrointestinal disturbances (GIDs). Genetics plays a substantial role in risk, but scientists also have determined that non-heritable factors can trigger the expression and severity of ASD symptoms. Clinical research studies from PI laboratories have focused on the gut-brain link that influences ASD symptoms, how a child functions and even responds to interventions . The investigators hypothesize that children with ASD will tolerate single endoscopic delivery of fecal transplant therapy which will modify their gut microbial profile leading to reduction of repetitive and rigid-compulsive behaviors, based on the Repetitive Behavioral Scales-Revised (RBS-R). Secondary outcomes include improved score in social responsiveness scale and gastrointestinal symptoms . Investigators propose a phase I safety study for the use of FMT in children with Autism Spectrum Disorder.
Tracking Information
- NCT #
- NCT03426826
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Sonia Michail, MD Children's Hospital Los Angeles Principal Investigator: Pat Levitt, Ph.D Children's Hospital Los Angeles