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Effect of behavioral improvement of L. reuteri CICC6132 in children with autism spectrum disorders

Effect of behavioral improvement of L. reuteri CICC6132 in children with autism spectrum disorders

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070783
Enrollment
Unknown
Registered
2023-04-23
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Autism-spectrum disorder

Interventions

High dose group:Oral 40 billion cfu L. reuteri CICC6132
low-dose group:Oral 20 billion L. reuteri CICC6132
matched group :rehabilitation training

Sponsors

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

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for autism in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and the diagnostic criteria for Classification and Diagnosis of Mental Disorders (CCMD-2) version 2; (2) the Autism Rating Scale (Childhood autism rating scale, CARS) 30 points; (4) age 2-6 years, no gender limit;

Exclusion criteria

Exclusion criteria: (1) Excluding other extensive developmental disorders and genetic autism with clear causes; (2) Using antibiotics, probiotics or other gastrointestinal treatment within 1 month prior to enrollment; (3) Autism clinical overall impression scale score as lack of symptoms or mild symptoms; (4) Patients with epilepsy, ADHD and other comorbidities; (5) Any behavior that prevents the principal interpretation of clinical judgment.

Design outcomes

Primary

MeasureTime frame
Infant-Junior High School Student’s Social Living Ability Scale,SM;Autism Behavior Checklist;ABC;

Secondary

MeasureTime frame
Trajectories of eye movements;childhood autism rating scale;CARS;child behavior checklist;CBCL;

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