The Gut-Brain Study

Status unconfirmed · Phase 1 · Has a placebo group

Conditions studied: Autism Spectrum Disorder (ASD), Gastro-Intestinal Disorder

In brief

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 (n=5) 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 (n=5) 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.

Key facts

Study ID

NCT03426826

Run by

Children's Hospital Los Angeles

People needed

10

Starts

2019-08-15

Expected to finish

2026-06-01

Last updated by the study team

2023-11-02

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital Los Angles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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