Clinical study for intervention effect of the probiotics in autistic children

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000028985

Enrollment

Unknown

Registered

2020-01-10

Start date

2019-05-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

Autism spectrum disorders

Interventions

Experimental group:Probiotic and prebiotic drink administration

Placebo group:maltodextrin supplementation

Eligibility

Sex/Gender

All

Age

3 Years to 9 Years

Inclusion criteria

Inclusion criteria: 1. ASDs were diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5); 2. the children ASD were between 3 and 9 years; 3. all participants in this study received a Chinese-based diet provided by the hospital caferia.

Exclusion criteria

Exclusion criteria: 1. Antibiotics, probiotics or prebiotics in 3 months before enrolling; 2. DHA, vitamin and other nutritional drugs; 3. Complicated with hyperactivity disorder and treated by aripiprazole, tomoxiden and other psychotropic drugs; 4. children guardians did not give permission for participation or did not complete follow-up.

Design outcomes

Primary

Measure	Time frame
alpha diversity;beta diversity;blood metabolites;faecal metabolites;ATEC scores;GI scores;	—

Contacts

Public ContactYing Wang

Qilu Children's Hospital of Shandong University

wangyingying67@163.com+86 18764080233

Outcome results

None listed

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