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Exploration on dynamic colonization and succession of gut microbiota after fecal microbiota transplantation for children with autism spectrum disorder

Exploration on dynamic colonization and succession of gut microbiota after fecal microbiota transplantation for children with autism spectrum disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097529
Enrollment
Unknown
Registered
2025-02-20
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-02-24

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

Shanghai Tenth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) Age 3-14 years old, male or female; (2) Meeting the ASD diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) of the American Psychiatric Association; (3) Accompanied with diarrhea, constipation, abdominal distension and/or food allergy/intolerance for at least 6 months and above symptoms occurred in the last 3 months; (4) Subjects and/or guardians sign the informed consent, and agree that the researcher will cooperate with the whole process of the clinical trial and collect clinical data, blood, saliva, urine and feces samples; (5) Able to swallow 3# FMT capsules by themselves.

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;

Secondary

MeasureTime frame
Autism Behavior Checklist;Childhood Autism Rating Scale;Bristol Stool Form Scale;Gastrointestinal Symptom Rating Scale;

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