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Clinical efficacy analysis and correlation study of intestinal flora transplantation therapy in children with ASD

Clinical efficacy analysis and correlation study of intestinal flora transplantation therapy in children with ASD - Microbial transplantation therapy in children with ASD

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126012
Enrollment
Unknown
Registered
2026-06-02
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Autism

Interventions

Control group:The enrolled patients received placebo treatment
Non matching treatment group:Non matching treatment group subjects will receive intestinal microbiota transplantation therapy with non matching donor and recipient populations
Individualized precision matching treatment group:Individualized and precise matching of donor gut microbiota transplantation therapy for enrolled patients

Sponsors

The First People's Hospital of Wuhu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. 3-10 years old, male or female not limited; 2. Diagnosed as a child with autism spectrum disorder according to DSM-V; 3. No serious mental disorders; 4. The guardian of the subject agrees to participate in this clinical trial and signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Use antibiotics in the past 3 months; 2. Emergency gastrointestinal diseases that rely on tube feeding and require timely medication treatment; 3.Diagnosed with severe malnutrition or excessive weight loss or severe immune deficiency diseases; 4. Has a history of severe allergies; 5. Accompanied by other serious illnesses; 6. Participated in other clinical studies within the previous month prior to screening; 7. Received attenuated live vaccine within 4 weeks prior to screening; 8. Presence of intestinal obstruction and active gastrointestinal bleeding; 9. Suffering from the following heart diseases: NYHA stage III or IV congestive heart failure, history of myocardial infarction or coronary artery bypass grafting (CABG) within =6 months prior to enrollment, clinically significant ventricular arrhythmia, or history of unexplained syncope (excluding cases caused by vasovagal or dehydration), history of severe non-ischemic cardiomyopathy; 10. Other researchers consider it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Clinical manifestations of autism;

Secondary

MeasureTime frame
Gastrointestinal function;Characteristics of gut microbiota;

Countries

China

Contacts

Public ContactGong Weida

The First People's Hospital of Wuhu

826889179@qq.com+86 553 267 9902

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026