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Effect of complex probiotics on gastrointestinal and behavioral problems in children with autism spectrum disorder based on trace elements and vitamin A/D

Effect of complex probiotics on gastrointestinal and behavioral problems in children with autism spectrum disorder based on trace elements and vitamin A/D

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081914
Enrollment
Unknown
Registered
2024-03-15
Start date
2024-03-15
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

Autism spectrum disorder

Interventions

Trace element or vitamin A/D deficiency group:complex probiotics
Trace element or vitamin A/D level normal group:complex probiotics

Sponsors

Qiqihar Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Age 3-10 years old, male and female; 2. Meet the diagnostic criteria for ASD in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3. Accompanied by diarrhea, constipation, abdominal distension and other gastrointestinal symptoms; 4. The subject and/or guardian sign informed consent, agreeing to cooperate with the researcher in the whole process of clinical trial and collect clinical data, peripheral blood and fecal samples.

Exclusion criteria

Exclusion criteria: 1. Having history of brain trauma, cerebral palsy, encephalitis and other organic brain diseases; 2. diagnosed with other mental illness; 3. There are organic intestinal diseases such as hirschsprung's disease, intestinal obstruction, intussusception, etc.; 4. Pathological intestinal inflammatory changes, such as inflammatory bowel disease; 5. In the last 3 months or in the next 6 months, there are plans to use antibiotics that affect the gut flora; 6. Have received FMT treatment within the last 12 months; 7. Have taken vitamin A/D, complex trace elements and other related drugs in the past 3 months.

Design outcomes

Primary

MeasureTime frame
gut microbiome;Trace elements and vitamins A and D;

Secondary

MeasureTime frame
Gut-related neurotransmitters;Gastrointestinal problem score;Childhood Autism Rating Scale;Child Behavior Checklist;

Countries

China

Contacts

Public ContactXiaolei Yang

Qiqihar Medical University

yxl0517@qmu.edu.cn+86 182 0462 7365

Outcome results

None listed

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