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Effect of Lactobacillus plantarum PS128 on behavior in children with autism spectrum disorders

Effect of Lactobacillus plantarum PS128 on behavior in children with autism spectrum disorders

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066545
Enrollment
Unknown
Registered
2022-12-08
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Autism-spectrum disorder

Interventions

Small-aged control group:Oral placebo
Small age experimental group:Oral of Lactobacillus plantarum PS128
Older experimental group:Oral of Lactobacillus plantarum PS128
Older control group:Oral placebo

Sponsors

Dalian Women and Children's Medical Center (Group)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for autism in children of the American Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and the diagnostic criteria for Classification and Diagnosis of Mental Disorders (CCMD-2); 2. Childhood autism rating scale (CARS) >=30 points; 3. Aged 2-7 years (less than 7 years old), no gender limit.

Exclusion criteria

Exclusion criteria: 1. Other widespread developmental disorders and autism with a clear genetic cause; 2. Antibiotics, probiotics or other gastrointestinal treatments were used within 1 month before enrollment; 3. Patients with epilepsy, ADHD and other comorbid diseases; 4. Any behavior that prevents the principal investigator of the clinical study from interpreting the results of the clinical judgment.

Design outcomes

Primary

MeasureTime frame
Social Responsiveness Scale, SRS;Child Behavior Checklist, CBCL;Autism Behavior Checklist, ABC;The arrival time of the first gaze was measured by an eye tracker;The duration of the first fixation point was measured by the eye tracker;

Countries

China

Contacts

Public ContactSun Jin

Dalian Women and Children's Medical Center (Group)

916054417@qq.com+86 13940831172

Outcome results

None listed

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