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Preliminary clinical study on probiotics Bacteroides fragilis BF839 in Children with Autism Spectrum Disorder (ASD)

Preliminary clinical study on probiotics Bacteroides fragilis BF839 in Children with Autism Spectrum Disorder (ASD)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035006
Enrollment
Unknown
Registered
2020-07-27
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-08-03

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

Conditions

Children with Autism Spectrum Disorder (ASD)

Interventions

experimental group:BF839
Control group:placebo

Sponsors

The Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Signing informed consent voluntarily; 2. The age is 2-10 years old (including 2 and 10 years old), with no gender limit; 3. Patients diagnosed with autism spectrum disorders in children according to the diagnostic and Statistical Manual of mental disorders (Fifth Edition, dsm-5) of the United States, or patients holding the diagnostic certificate of autism spectrum disorders of the Third Affiliated Hospital of Sun Yat sen University. 4. No antibiotics, probiotics, ketogenic diet, fecal bacterial transplantation, proton pump and other treatments affecting gastrointestinal tract were received within one month before enrollment. 5. Be able to receive follow-up visit, follow-up examination and specimen collection on time.

Exclusion criteria

Exclusion criteria: 1. The treatment plan (including any treatment) was just changed in the past month. 2. Other clinical trials were conducted within one month; 3. Children have schizophrenia, depression or organic brain dysplasia, brain tumors; 4. Children suffer from other unstable or serious heart, lung, liver, kidney and hematopoietic system diseases (including unstable angina pectoris, uncontrollable asthma, active gastric bleeding, cancer, etc.); 5. The guardian of the child did not agree to participate in the follow-up study or follow-up.

Design outcomes

Primary

MeasureTime frame
ABC scale;CARS scale;SRS scale;Social life ability scale for 0-year-old junior high school students;GSRS;CBCL scale;

Countries

China

Contacts

Public ContactLin Chuhui

The Second Affiliated Hospital of Guangzhou Medical University

175586863@qq.com+86 020-34152843

Outcome results

None listed

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