Fecal Microbiota Transplantation in Children With ASD
Recruiting
N/A
Interventional Study
Autism Spectrum Disorder
At a Glance
- Age
- 3 – 16
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1 (estimated)
- Sponsor
- Shenzhen Children's Hospital · Government
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About This Trial
This is a single-center, randomized, double-dummy, triple-blind, placebo-controlled, three-arm parallel-group superiority trial. The study aims to compare the efficacy and safety of Fecal Microbiota Transplantation (FMT) administered via two different invasive routes-nasojejunal tube (NJT) and colonoscopy-versus a placebo control in children aged 3-16 years with moderate-to-severe Autism Spectrum …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Aged 3-16 years.
* Diagnosed with ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a Childhood Autism Rating Scale (CARS) total score ≥36 (moderate-to-severe autism).
* Legal guardians fully comprehend the trial's informed…
Contacts