Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

Assessment of Customized Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04655326
• Other study ID #: STUDY00012299
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: October 15, 2020
• Est. completion date: December 15, 2024

Study information

• Verified date: February 2024
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study of the effect of a customized probiotic on children and adults with autism, including effects on autism symptoms and gastrointestinal symptoms.

Description:

SunGenomics provides its customers with a customized probiotic based on an analysis of the microbiota in their stool samples. Customers who have autism spectrum disorders are invited to participate in this study by completing several questionnaires about their medical history, diet, autism symptoms, and gastrointestinal symptoms before taking the probiotic, and to repeat those questionnaires approximately 3 months later. This is effectively an open-label study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Months to 75 Years

Eligibility

Inclusion Criteria:

1. New client of Sun Genomics (has applied for testing and treatment, but not yet begun treatment)

2. Diagnosis of ASD (initially based on self-report of ASD diagnosis by appropriate medical professional, and then verified by an evaluation of the Social Responsiveness Scale (SRS-2) by ASU staff.

3. Children and adults ages 2.5-75 years

Exclusion Criteria:

1. Antibiotic use in the last two months (not counting topical antibiotics)

2. Any changes in medications, nutritional supplements, therapies, in the last two months, or any plans to change them during the first 3 months of probiotic treatment.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Biological:
• Flore
personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Sun Genomics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Global Impressions of Autism	questionnaire which assesses 20 different autism-related symptoms on a 7-point scale	change in score between baseline and 3 months
Secondary	Social Responsiveness Scale	A questionnaire about social skills, where higher scores suggest more severe autism. Scores range from 0 to 195, with higher scores indicating more severe problems.	change in score between baseline and 3 months
Secondary	Gastrointestinal Symptom Rating Scale	A questionnaire which evaluates 15 gastrointestinal symptoms on a severity scale from 1 (none) to 7 (severe)	change in score between baseline and 3 months

External Links

•   link to official study ad