Application of Probiotic PS128 in Children With ASD

• Status: Enrolling by invitation
• Trial end date: 2023-10-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the role of probiotics PS128 in improving gastrointestinal dysfunction and core behavioral symptoms in children with ASD, and investigate the underlying etiological mechanisms of ASD.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yan Hao

Criteria

Inclusion Criteria:

1. Children aged 2-5 years with ASD from Tongji hospital (both boys and girls);

2. meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and ADOS-2 diagnostic criteria;

3. No significant abnormalities on head MRI or EEG;

4. If psychotropic medication is required during the project, the psychiatrist must confirm that medication is stable during this period (no change in dose or type of medication);

5. Willing to provide samples such as blood, urine and feces.

Exclusion Criteria:

1. Take antibiotics or antifungal drugs within 15 days prior to the project.

2. Take probiotic products within 30 days prior to the project.

3. Have acute diarrhea within 30 days prior to the project.

4. Start taking new psychotropic medication within 15 days prior to the project.

5. Have severe hearing, visual or motor impairment.

6. Accompany with other mental behavioral disorders, such as schizophrenia, bipolar disorder.

7. A history of Rett syndrome, chromosomal, inherited metabolic disorders and other significant somatic disorders.

8. A history of organic gastrointestinal disorders (e.g., gastroesophageal reflux, food allergies, inflammatory bowel disease), history of intestinal surgery, intestinal obstruction, intestinal perforation, intestinal bleeding, multi-organ failure, and severe immunodeficiency disorders

9. Have a special diet (e.g., gluten-free diet, casein-free diet, ketogenic diet, etc.)

10. Co-morbidities in children with ASD were documented and discussed in detail by two or more behavioral developmental behaviorists, and children with ASD who required immediate rehabilitation or neurological analogs for co-morbidities were not allowed to enter this study.