Skip to content

Clinical efficacy and safety analysis of fecal microbiota transplantation in the treatment of children with autism spectrum disorder complicated with gastrointestinal symptoms

Clinical efficacy and safety analysis of fecal microbiota transplantation in the treatment of children with autism spectrum disorder complicated with gastrointestinal symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099942
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Autism spectrum disorder

Interventions

Observation group:None

Sponsors

Shanghai Tenth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) Age 2-18 years old, male or female; (2) Meeting the diagnostic criteria of ASD in the fifth edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) of the American Psychiatric Association; (3) Accompanied by gastrointestinal symptoms such as diarrhea, constipation, abdominal distension, dyspepsia, abnormal gastrointestinal exhaust, food allergy/intolerance for at least 6 months, and the above symptoms have occurred in the past 3 months; (4) The subjects and/or their guardians signed the informed consent, agreed to cooperate with the whole process of the clinical trial and to collect clinical data.

Exclusion criteria

Exclusion criteria: (1) Diagnosis of Rett syndrome. (2) Previous history of brain injury, cerebral palsy, encephalitis or other brain organic diseases; (3) Diagnosis of other mental diseases; (4) Diagnosis of intestinal organic diseases, such as congenital megacolon, intestinal obstruction, intussusception, inflammatory bowel disease and etc. (5) There are pathological intestinal inflammatory changes, such as inflammatory bowel disease (6) Severe obesity or severe malnutrition (7) There is a planned use of probiotics and antibiotics in the past 3 months or in the next 6 months drugs that sound intestinal flora; (8) Have received FMT treatment in the past 12 months;

Design outcomes

Primary

MeasureTime frame
Diversity and richness of flora;Assessment of ASD Symptoms;Assessment of bowel symptoms;

Secondary

MeasureTime frame
The a diversity and ß diversity of intestinal flora increased from baseline;Changes in symptoms of other comorbidities such as allergy, asthma, dermatitis, and metabolic syndrome in patients;

Countries

China

Contacts

Public ContactYang Rong

Shanghai Tenth People’s Hospital

yangrongtongji@163.com+86 133 2191 7107

Outcome results

None listed

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