Status:
ACTIVE_NOT_RECRUITING
The Gut-Brain Study
Lead Sponsor:
Children's Hospital Los Angeles
Conditions:
Autism Spectrum Disorder (ASD)
Gastro-Intestinal Disorder
Eligibility:
All Genders
5-17 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find out if transplant of fecal matter (stool), also known as fecal microbiota transplantation (FMT), from a healthy person into the intestines of children and young ad...
Detailed 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 interes...
Eligibility Criteria
Inclusion
- Age: 5-17 who have been diagnosed with non-syndromic ASD-s
- Needs upper GI endoscopy
- Clinical Assessment of ASD
- ADOS validated diagnoses of ASD
- Questionnaires: RBS-2 , KBIT, SRS, Rome III Version (QPGS- RIII), Ped QL, SSP
Exclusion
- Subjects able to give consent/assent but unwilling to give informed consent/assent
- Prematurity (\<36 weeks)
- Pregnancy: testing will be done on FMT day 0 for subjects with childbearing potential
- Subjects with significant renal and liver dysfunction (creatinine \> 2 mg/dl and direct bilirubin \> 2 mg/dl)
- Subjects with congenital or acquired immunodeficiency, or who are immunosuppressed such as neoplastic disease or organ transplantation), have received or are receiving chemotherapy, or have been diagnosed with HIV.
- Subjects with syndromic disorders of defined genetic cause, and subjects who have severe sensory or motor problems (for example, blindness, deafness, seizures, cerebral palsy)
- Subjects with severe food allergies
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03426826
Start Date
August 15 2019
End Date
June 1 2026
Last Update
November 2 2023
Active Locations (1)
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1
Children's Hospital Los Angles
Los Angeles, California, United States, 90027