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The role of probiotics in children with autism spectrum disorders: a randomized controlled trial.

The role of probiotics in children with autism spectrum

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037941
Enrollment
Unknown
Registered
2020-09-04
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-30

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

Conditions

Autism Spectrum Disorders

Interventions

Sponsors

The Third Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Patients with ASD diagnosed by dsm-5; 2. Patients aged 3-12 years; 3. Patients who voluntarily participated in the trial and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who took antibiotics and antifungal drugs within three months; 2. Patients with special diet: such as no gluten, casein diet, or special carbohydrate diet; 3. Patients who take other prebiotics, probiotics and antioxidants within three months; 4. Patients with diarrhea or fever within one week; 5. Patients with other neurological symptoms such as epilepsy; 6. Crohn's disease, inflammatory bowel disease, food intolerance and other gastrointestinal diseases; 7. Patients with liver diseases; 8. Patients with type 1 diabetes mellitus; 9. Definite diagnosis of Rett syndrome (RTT) and other genetic metabolic diseases.

Design outcomes

Primary

MeasureTime frame
Autism Treatment Evaluation Checklist (ATEC);

Secondary

MeasureTime frame
Gastrointestinal assessment questionnaires (GSRS);Bristol stool chart;Children Sleep Habit;polysomnography (PSG);parenting stress scale short form (PSI-SF);metabonomics of Fecal, blood and urine;Changes in Inflammatory Profile;Diversity and richness of flora;

Countries

China

Contacts

Public ContactZhu Changlian

The Third Affiliated Hospital of Zhengzhou University

zhuc@zzu.edu.cn+86 13526520357

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026