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Study on the improvement effect of probiotics on autistic spectrum disorders

Probiotics modulates abnormal behavior and gut microbiota of patients with ASD

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057450
Enrollment
Unknown
Registered
2022-03-12
Start date
2022-03-18
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

autism spectrum disorder

Interventions

Control:placebo
Experimental ?:probiotics(CFU=3x10^10/day)
Experimental ?:probiotics(CFU=1x10^11/day)

Sponsors

Jinan Central Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of ASD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5); 2. Age 3–10 years; 3. History of chronic constipation, subjects reported an average of = 3 spontaneous bowel movements per week for at least 3 months prior to screening visits.

Exclusion criteria

Exclusion criteria: 1. Schizophrenia, other psychosis, and mood disorders, including bipolar disorder and major depressive disorder according to the DSM-V criteria; 2. Seizure attack in the past year; 3. History of severe head trauma or stroke; 4. Suffering from serious infectious diseases or infectious diseases.

Design outcomes

Primary

MeasureTime frame
Autism Behavior Checklist;Oral/Gut Microbiota;Metabonomics;Gastrointestinal Symptoms;Cytokine;

Countries

China

Contacts

Public ContactHuajun Zheng

Shanghai Institutue for Biomedical and Pharmaceutical Technologies

zhenghj@chgc.sh.cn+86 21 34617495

Outcome results

None listed

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