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Effects of probiotics on social behavior, serum biochemical parameters, and intestinal/oral flora in children with autism spectrum disorders and Prader-Willi Syndrome

Effects of probiotics on social behavior, serum biochemical parameters, and intestinal/oral flora in children with autism spectrum disorders and Prader-Willi Syndrome

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022646
Enrollment
Unknown
Registered
2019-04-20
Start date
2019-05-01
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

Autism spectrum disorder and Prader-Willi Syndrome

Interventions

experimental group:phase I: probiotics
control group:phase I: placebo
phase II: probiotics

Sponsors

The Second Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 22 Years

Inclusion criteria

Inclusion criteria: 1.1 All participants shall meet the following inclusion criteria: 1.1.1 Aged 2-10 years; 1.1.2 Autism was diagnosed with The Fifth Edition of The Diagnostic and Statistical Manual of Mental Disorders (dsm-5), The ADOS and/or The adi-r; 1.1.3 Gastrointestinal symptoms, such as diarrhea, constipation and other abdominal discomfort; 1.1.4 IQ is 80 or above.

Exclusion criteria

Exclusion criteria: 1.2 Exclusion criteria: 1.2.1 Pregnant women (before or during the study); 1.2.2 A history of other neurological and/or psychiatric disorders, such as seizures, schizophrenia, or substance abuse; 1.2.3 Current use of psychotropic drugs; 1.2.4 History of use of oxytocin and probiotics.

Design outcomes

Primary

MeasureTime frame
T lymphocyte subset;serum biochemical parameters;Cytokine;Oral/intestinal microflora sequencing;Sociological behavior score;

Countries

China

Contacts

Public ContactXia Cao

The Second Affiliated Hospital of Kunming Medical Univ

1244815508@qq.com+86 13518769225

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 22, 2026