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Clinical Evaluation of Probiotics on Autism Spectrum Disorder and Gut Microbiota Dysbiosis

Clinical Evaluation of Probiotics on Autism Spectrum Disorder and Gut Microbiota Dysbiosis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052439
Enrollment
Unknown
Registered
2021-10-26
Start date
2021-10-25
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

autism spectrum disorder

Interventions

Placebo group:fructo-oligosaccharide
Bifidobacterium breve group:One bag of probiotics per day ( CFU >= 10 ^ 9 )
Bifidobacterium bifidum group:One bag of probiotics per day ( CFU >= 10 ^ 9 )

Sponsors

Affiliated Hospital of Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for the ASD group: diagnosed as ASD by a child health care physician with rich experience in the clinical diagnosis and treatment of ASD, and the diagnosis conformed to the definition in the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-5). diagnostic criteria; 2. Inclusion criteria for the normal control group: no history of any neuropathic or psychiatric disease; 3. Age 2-10 years old 4. The family members agreed to participate in this interview and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Gastrointestinal surgery; 2. Patients with severe disability; 3. Suffering from serious infectious diseases or infectious diseases; 4. Those who cannot provide correct information; 5. No relatives accompany the patient.

Design outcomes

Primary

MeasureTime frame
Social responsiveness scale;Autism behavior checklist;PEP-3;Gastrointestinal Symptoms-Rome IV;Fecal flora 16S rRNA amplicon sequencing;metabonomics;

Countries

China

Contacts

Public ContactWang Gang

Jiangnan University

wanggang@jiangnan.edu.cn+86 15852818722

Outcome results

None listed

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