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Supplementation with compound probiotics powder improves autism in children: a single-center, double-blind, two-group, randomized controlled clinical study

Supplementation with compound probiotics powder improves autism in children: a single-center, double-blind, two-group, randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086811
Enrollment
Unknown
Registered
2024-07-11
Start date
2024-07-31
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

Autism

Interventions

Probiotics group:Compound bacterial powder+maltodextrin

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 13 Years

Inclusion criteria

Inclusion criteria: (1) Age range from 3 to 13 years old, regardless of gender; (2) Meets 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 gastrointestinal symptoms such as diarrhea, constipation, bloating, and/or food allergies/intolerance, with symptoms occurring for at least 6 months and more symptoms occurring in the past 3 months; (4) The subject and/or guardian sign an informed consent form, agreeing that the researcher will cooperate throughout the clinical trial process and collect clinical data, peripheral blood, and fecal samples, and be able to cooperate in completing brain fMRI examinations;

Exclusion criteria

Exclusion criteria: (1) Clear diagnosis of Rhett's syndrome (2) Clear history of organic brain diseases such as traumatic brain injury, cerebral palsy, and encephalitis (3) Individuals diagnosed with other mental illnesses (4) Existence of intestinal organic lesions such as congenital megacolon, intestinal obstruction, intussusception, etc (5) There are pathological changes in intestinal inflammation, such as inflammatory bowel disease, etc (6) Severe obesity or severe malnutrition (7) Planned use of probiotics, antibiotics, and other drugs that clearly affect gut microbiota within the past 3 months or within the next 6 months (8) Received FMT treatment within the past 12 months

Design outcomes

Primary

MeasureTime frame
ABC scale;CARS scale;

Secondary

MeasureTime frame
lymphocyte;cytokines;

Countries

China

Contacts

Public Contactyang rong

Shanghai Tenth People's Hospital

970432146@qq.com+86 158 0191 3786

Outcome results

None listed

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