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Probiotic products with high production of 5-HTP are used in clinical research to intervene in children with autism

Probiotic products with high production of 5-HTP are used in clinical research to intervene in children with autism

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100210
Enrollment
Unknown
Registered
2025-04-03
Start date
2024-12-06
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Autism

Interventions

Viable bacteria preparation intervention group:Oral probiotic preparation treatment with high production of 5-HTP: direct oral administration or warm boiled water and other preparations daily, dosage
Take it continuously for 6 months. Antimicrobials need to be discontinued or cross-used during the course of the treatment study.
Placebo group:Placebo is taken directly orally or with warm water every day, with a dosage of 1 bag (2g)/time, 2 times/d

Sponsors

Maternal and Child Health Hospital of Hubei Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1. Patient age: 3-8 years old. 2. Patients diagnosed with childhood autism using international standards, and have not used antibiotics or antibiotic drugs within two weeks before treatment, have no severe diarrhea, and have a regular diet. 3. Special comprehensive intervention treatment for children with autism is planned.

Exclusion criteria

Exclusion criteria: 1. Failure to carry out special comprehensive intervention treatment for children with autism; 2. The final diagnosis was not childhood autism; 3. Other conditions (e.g., severe food allergies, etc.) that are not suitable for intervention by the physician.

Design outcomes

Primary

MeasureTime frame
Metabolomics differences;Metagenomic differences;

Countries

China

Contacts

Public ContactZiming Huang, Hong Wang

Maternal and Child Health Hospital of Hubei Province

378818918@qq.com+86 138 0860 5018

Outcome results

None listed

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