Skip to content

Prospective Study on the Effects of Bifidobacterium MCC1274 in Children with Autism Spectrum Disorder

Prospective Study on the Effects of Bifidobacterium MCC1274 in Children with Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103178
Enrollment
Unknown
Registered
2025-05-26
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Autism spectrum disorder

Interventions

Bifidobacterium MCC1274 group:Bifidobacterium MCC1274 capsules or powder, take 1 capsule with warm water daily for 12 consecutive weeks.

Sponsors

Shanghai Children’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1.5 Years to 18 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with ASD according to the diagnostic criteria for ASD in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V); Aged between 18 months and 18 years; Presenting with gastrointestinal symptoms (such as dyspepsia, constipation, diarrhea, etc.).

Exclusion criteria

Exclusion criteria: Children with schizophrenia and other psychoses defined by the DSM-V criteria, excluding those with comorbid mood disorders and ASD; Seizures in the past year; A history of severe head injury or stroke; Suffering from severe infectious or communicable diseases; Having taken antibiotics, probiotics, or acid suppressants in the past three months; Having received fecal microbiota transplantation treatment in the past three months.

Design outcomes

Primary

MeasureTime frame
The score of the Childhood Autism Rating Scale (CARS);The score of the Autism Behavior Rating Scale (ABC);The score of the Social Responsiveness Scale (SRS);The score of the Gastrointestinal Symptom Rating Scale (GSRS);

Secondary

MeasureTime frame
The score of the Sleep Disturbance Scale for Children (SDSC);

Countries

China

Contacts

Public ContactZhang Ting

Shanghai Children’s Hospital

zhangt@shchildren.com.cn+86 180 1648 7615

Outcome results

None listed

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