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Clinical Study on the Therapeutic Effects of the Real-World Combined BF839 Mixed Probiotic Preparation on Children with Autism Spectrum Disorder

Clinical Study on the Therapeutic Effects of the Real-World Combined BF839 Mixed Probiotic Preparation on Children with Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126153
Enrollment
Unknown
Registered
2026-06-04
Start date
2025-01-15
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 Spectrum Disorder (ASD)

Interventions

Research Group:Conventional rehabilitation training, BF839 (Bacteroides fragilis 839) mixed probiotic treatment.
Control Group:Conventional rehabilitation training

Sponsors

Beijing Childrens Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 5 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 2 years and <= 5 years, regardless of gender; 2.Diagnosis based on the criteria for ASD in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3.The subjects have been consistently receiving rehabilitation training and will be able to maintain regular rehabilitation training for the next six months; 4.No severe congenital diseases, genetic metabolic diseases, other major neurological diseases, or immune system diseases; 5.No severe food allergies or intolerances; 6.No severe infectious diseases in the past month; 7.No history of fecal microbiota transplantation; 8.Voluntarily using the BF839 mixed probiotic preparation.

Exclusion criteria

Exclusion criteria: 1.Children with other unstable or severe heart, lung, liver, kidney, or hematological diseases (including unstable angina, uncontrolled asthma, active gastrointestinal bleeding, cancer, etc.); 2.Children in the probiotic application group who are unable to regularly take probiotics or are unable to attend assessments and follow-ups on time for various reasons.

Design outcomes

Primary

MeasureTime frame
Other-rating scale scores;Self-rating scale scores;

Countries

China

Contacts

Public ContactLiang Aimin

Beijing Childrens Hospital,Capital Medical University

liang-aimin@163.com+86 10 59616384

Outcome results

None listed

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