NCT04948814

Application of Fecal Microbiota Transplantation in Children With ASD

Clinical Trial of Fecal Microbiota Transplantation in Children With Autism Spectrum Disorder

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Accepted

Summary

Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. Intestinal microbial disturbance is common in children with ASD, and about 40% of ASD children suffer from gastrointestinal dysfunction. A great deal of evidence shows that intestinal microbes can influence the brain to play its role through "brain-intestinal-microbiota axis". Fecal microbial biota transplantation (FMT) is the most direct way to change the intestinal flora rapidly. We intend to study the difference of intestinal flora structure and metabolism between ASD children and control children at the level of phylum, genus and species; To explore the role of fecal bacteria transplantation in improving core symptoms and gastrointestinal dysfunction of children in autism spectrum disorder; To study the potential etiological mechanism of autism spectrum disorder.

Detailed description

20 ASD children and 20 healthy children who are 3 to 18 years of age will be enrolled in the trial. The fecal donors who are 20 healthy children, will be extensively screened for infectious diseases prior to providing stool for the transplant. After being informed about the study and potential risks, all patients giving written informed consent will undergo screening period to determine eligibility for study entry. 20 ASD children who meet the eligibility requirements will receive a fecal microbiota transplantation following a 2-week treatment with Vancomycin. Fecal bacteria transplantation will be achieved through nasogastric tube, nasojejunal tube, esophagogastroduodenoscopy, colonoscopy or enema. The amount of fecal bacterial liquid transplantation for children is 5ml/kg each time. Microbiota analysis will also be performed on both the donor and recipient stool sample prior to transplantation, and on the recipient sample at 1 month, 3 month and 6 months post transplantation. We evaluate the difference of intestinal flora structure and metabolism between ASD children and control children at the level of phylum, genus and species, and explore the role of fecal bacteria transplantation in improving core symptoms and gastrointestinal dysfunction of children in autism spectrum disorder.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Fecal microbiota transplantation	FMT utilizing stool from healthy children
DRUG	Vancomycin	40mg/kg/day

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2021-07-02
• Last updated: 2023-01-20

Locations

1 site across 1 country: China