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An observational study of intestinal flora and metabolites in children with autism complicated with gastrointestinal dysfunction

An observational study of intestinal flora and metabolites in children with autism complicated with gastrointestinal dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052106
Enrollment
Unknown
Registered
2021-10-17
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Autism

Interventions

Autism with gastrointestinal dysfunction group:N/A
Autism without gastrointestinal dysfunction group:N/A

Sponsors

Zhongshan Hospital, Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria of ASD group with gastrointestinal dysfunction: (1) Aged 3 to 10 years, in America's "medical diagnostic and statistical manual of mental disorders" fifth edition (DSM -V) standard: 1)Children's Autism Rating Scale (CARS) >=30 points; 2) Total score of autism Behavior Scale (ABC) >=67; (2) It conforms to the Childhood Functional Gastrointestinal Disorders(2016). (3) The guardian of the patient signed an informed consent to allow the investigator to collect clinical data, peripheral blood, feces and other samples; 2. Inclusion criteria of ASD group without gastrointestinal dysfunction: (1) Aged 3 to 10 years, in line with the DIAGNOSTIC and Statistical Manual of Mental Disorders (DSM-5) : 1) Children's Autism Rating Scale (CARS) >=30 points; 2) Total score of autism Behavior Scale (ABC) >=67; (2) No gastrointestinal symptoms such as constipation and diarrhea; (3) The guardian of the patient signed an informed consent to allow the investigator to collect clinical data, peripheral blood, feces and other samples. 3. Inclusion criteria for healthy control group: (1) Aged 3 to 10 years; (2) In good health, without a clearly diagnosed disease.

Exclusion criteria

Exclusion criteria: 1. Rett Syndrome (RTT) was definitely diagnosed; 2. Have a clear history of brain injuries, cerebral palsy, encephalitis and other organic brain diseases; 3. Family members report a history of serious mental illness or substance abuse; 4. Those who have used probiotics, antibiotics, acid suppressors and other drugs affecting intestinal flora in the last 3 months; 5. The presence of intestinal organic diseases, such as congenital megacolon, intestinal obstruction, intussusception and developmental disorders related genetic diseases; 6. Developmental quotient (DQ) score <35; 7. Participants in other clinical trials that affect the evaluation of the study results. Those with one of the above conditions were excluded from the study.

Design outcomes

Primary

MeasureTime frame
Childhood Autism Rating Scale;Behavioral Checklist for Children with Autism;Gastrointestinal Disorder Rating Scale;feces 16sRNA;feces metabonomics;

Countries

China

Contacts

Public ContactHe Jianquan

Zhongshan Hospital, Xiamen University

hejianquan08@163.com+86 592 5896452

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026