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Fecal microbiota transplantation in the treatment of young Chinese children with autism spectrum disorders: a multicenter double-blind randomized controlled trial

Fecal microbiota transplantation in the treatment of young Chinese children with autism spectrum disorders: a multicenter double-blind randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033736
Enrollment
Unknown
Registered
2020-06-11
Start date
2019-10-01
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism spectrum disorder

Interventions

control group:Dry frozen powder capsule made by water

Sponsors

Department of Colorectal Disease, Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 10 Years

Inclusion criteria

Inclusion criteria: (1) Aged 3-10 years old; (2) In line with DSM-V standard, the Childhood Autism Rating Scale (CARS) >=30 points (supplementary test is needed if the test has not been done); the total score of the Autism Behavior Checklist (ABC) >=67 points (supplementary test is needed if the test has not been done); (3) The diagnosis of chronic constipation was in accordance with the Rome IV standard; (4) The guardian of the patient signed the informed consent and agreed the researcher to collect clinical data and peripheral blood, saliva, urine, feces and other samples; (5) Need to be able to swallow children's capsules; (6) The patients were followed up for 6 months.

Exclusion criteria

Exclusion criteria: (1) Rett syndrome (RTT) was definitely diagnosed; (2) Have a clear history of brain injury, cerebral palsy, encephalitis and other brain organic diseases; (3) Those who are definitely diagnosed as other mental diseases; (4) Those who used probiotics, antibiotics, antacids and other drugs affecting intestinal flora in the past 3 months; (5) There are organic diseases such as Hirschsprung's disease, intestinal obstruction and intussusception; (6) Poor compliance.

Design outcomes

Primary

MeasureTime frame
Autism Behavior Checklist;Childhood Autism Rating Scale (CARS);

Secondary

MeasureTime frame
Wexner scale;Gastrointestinal Quality of Life Index;Diversity and richness of flora;Levels of short chain fatty acids and bile acids;

Countries

China

Contacts

Public ContactLi Ning

Department of Colorectal Disease, Shanghai Tenth People's Hospital

15950192128@163.com+86 15896453859

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026