Application of Probiotic PS128 in Children With ASD

Yan Hao

Status and phase: Invitation-only; Phase 1

Conditions: Autism Spectrum Disorder

Treatments: Drug: placebo (Microcrystalline cellulose ); Biological: probiotics PS128

Study type: Interventional

Funder types: Other

Identifiers

NCT04942522

S313

Details and patient eligibility

About

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.

Full description

After being informed about the study and potential risks, all patients giving written informed consent will undergo screening period to determine eligibility for study entry. Participants who meet the eligibility requirements will be randomized in a double-blind manner(participant and investigator) in a 1:1 ratio to probiotics PS128 group or placebo group. Each patient acts as his or her own control, and they receive both the study drug as well as the placebo. After a washout period, the participants will be switched throughout to different treatments（probiotics placebo group or PS128 group）.

Enrollment: 80 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

ASD children A

Experimental group

Description:

Participants received probiotics PS128 \[6×10\^10 CFU(colony forming unit)/capsule} one capsule orally twice daily for 8 weeks. After a washout period (4 weeks), they then received placebo(450mg/capsule) one capsule orally twice daily for 8 weeks. Stool, urine and blood specimen will be collected at baseline, week 8, week 12 and week 20.

Treatment:

Drug: placebo (Microcrystalline cellulose )

Biological: probiotics PS128

ASD children B

Experimental group

Description:

Participants received placebo(450mg/capsule) one capsule orally twice daily for 8 weeks. After a washout period (4 weeks), they then received probiotics PS128(6×10\^10 CFU/capsule) one capsule orally twice daily for 8 weeks. Stool, urine and blood specimen will be collected at baseline, week 8, week 12 and week 20.

Treatment:

Drug: placebo (Microcrystalline cellulose )

Biological: probiotics PS128