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Efficacy and safety of probiotics combined with behavior training in the treatment of autism

Efficacy and safety of probiotics combined with behavior training in the treatment of autism - a randomized, double-blind and controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050825
Enrollment
Unknown
Registered
2021-09-04
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-09

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

Conditions

Autism spectrum disorder

Interventions

Treatment group:Probiotics combined with behavioral therapy
Placebo group:Placebo

Sponsors

Beijing Anding Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of ASD in the diagnostic and Statistical Manual of mental disorders, 5th Edition (DSM-5) and Autism Diagnostic Observation Schedule (ADOS); 2. Aged 3 to 6 years, both boys and girls; 3. The total CARS score must be greater than 30, and 2 points or above for at least one symptom on the 6-GSI scale; 4. The subject and legal guardian were fully informed and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with nervous system, mental disorders and severe physical diseases; 2. Subjects who have received any surgical treatment, vagus nerve stimulation, deep brain stimulation or stem cell therapy for autism; 3. Those who have taken DHA, vitamins and other nutritional drugs within 1 month or psychiatric drugs within 3 months; 4. Those who have taken antibiotics and probiotics within 1 month; 5. Other situations that the researcher believes the subject should not participate.

Design outcomes

Primary

MeasureTime frame
Autism Treatment Evaluation Checklist;Six gastrointestinal severity index;Childhood Autism Rating Scale (CARS);

Secondary

MeasureTime frame
Autism Behavior Checklist (ABC);

Countries

China

Contacts

Public ContactHe Fan

Beijing Anding Hospital Affiliated to Capital Medical University

fanhe@mail.ccmu.edu.cn+86 18310806619

Outcome results

None listed

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