Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03426826
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-02
First Post:
2018-02-02
Brief Title:
The Gut-Brain Study
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
Dynamics of Gut Microbiomes in Autism Spectrum Disorder ASD Symptoms
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 adults with Autism Spectrum Disorder ASD
For this study children between the ages of 5-17years will be recruited over 2 years Children will be recruited who receive an ASD diagnosis using the gold-standard Autism Diagnosis Observation Schedule -2 ADOS-2 using module 1 2 or 3 none limited or no moderate expressive language Children diagnosed with these modules of the ADOS-2 may be at greater risk for GI disorders and rigid-compulsive behaviors Additional assessment of rigid-compulsive behaviors and social communication will be done using the Repetitive Behavioral Scales-Revised RBS-R and Social Responsiveness Scale-2 SRS-2 respectively KBIT the Kaufman Brief Intelligence Test is used at baseline to obtain patient IQ Total evaluation time is approximately 90 minutes Following baseline symptom evaluation a medical exam will be performed to determine whether each child is expressing specific GI symptoms In addition parents will fill out the Questionnaire for Pediatric Gastrointestinal Symptoms- Rome III QPGS-III Once an ASD diagnosis is confirmed FMT treatment will be initiated which typically occurs within 4-6 weeks of the initial diagnosis Half 50 of the children n5 will receive the equivalent of 50 g of stools from a healthy donor into the jejunum through upper endoscopy and the other 50 off children n5 will receive Saline solution as Placebo control through upper endoscopy
Subjects will have a total of 5 visits within 24 weeks including phone call follow up on Day 7 after FMT
For this study children between the ages of 5-17years will be recruited over 2 years Children will be recruited who receive an ASD diagnosis using the gold-standard Autism Diagnosis Observation Schedule -2 ADOS-2 using module 1 2 or 3 none limited or no moderate expressive language Children diagnosed with these modules of the ADOS-2 may be at greater risk for GI disorders and rigid-compulsive behaviors Additional assessment of rigid-compulsive behaviors and social communication will be done using the Repetitive Behavioral Scales-Revised RBS-R and Social Responsiveness Scale-2 SRS-2 respectively KBIT the Kaufman Brief Intelligence Test is used at baseline to obtain patient IQ Total evaluation time is approximately 90 minutes Following baseline symptom evaluation a medical exam will be performed to determine whether each child is expressing specific GI symptoms In addition parents will fill out the Questionnaire for Pediatric Gastrointestinal Symptoms- Rome III QPGS-III Once an ASD diagnosis is confirmed FMT treatment will be initiated which typically occurs within 4-6 weeks of the initial diagnosis Half 50 of the children n5 will receive the equivalent of 50 g of stools from a healthy donor into the jejunum through upper endoscopy and the other 50 off children n5 will receive Saline solution as Placebo control through upper endoscopy
Subjects will have a total of 5 visits within 24 weeks including phone call follow up on Day 7 after FMT
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None