Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

Early Phase 1

Active, not recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Biological: Flore

• Registration Number: NCT04655326
• Lead Sponsor: Arizona State University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-03
• Last Update Posted: 2024-02-06
• Primary Completion: 2024-08-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Flore	Each participant receives a customized probiotic based on the results of the test of their microbiota

Primary Outcome Measures

Name	Time	Method
Parent Global Impressions of Autism	change in score between baseline and 3 months	questionnaire which assesses 20 different autism-related symptoms on a 7-point scale

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom Rating Scale	change in score between baseline and 3 months	A questionnaire which evaluates 15 gastrointestinal symptoms on a severity scale from 1 (none) to 7 (severe)
Social Responsiveness Scale	change in score between baseline and 3 months	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.

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Tempe, Arizona, United States