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Fecal microbiota transplantation for children with ASD: a multicenter, randomized, double-blind controlled study

Fecal microbiota transplantation for children with ASD: a multicenter, randomized, double-blind controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035624
Enrollment
Unknown
Registered
2020-08-15
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-08-31

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

Conditions

Autism spectrum disorder

Interventions

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 3 to 10 years; 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
Childhood Autism Rating Scale (CARS);

Secondary

MeasureTime frame
Autism Behavior Checklist;Bristol Stool Form Scale;Patient Generated Index;Gastrointestinal Quality of Life Index;Diversity and richness of flora;Levels of short chain fatty acids and bile acids;

Countries

China

Contacts

Public ContactQin Huanlong

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