Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

• Sponsor: Arizona State University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04655326
• Collaborator: Sun Genomics (Other)
• Enrollment: 1,000
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 28.9
• Patients Per Site Per Month: 34.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Biological: Flore	Early Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Each participant receives a customized probiotic based on the results of the measurement of their gut microbiotaEach participant receives a customized probiotic based on the results of the measurement of their gut microbiota
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessment of Customized Probiotic Therapy for Children and Adults With Autism Spectrum Disorder
• Actual Study Start Date: Oct 15, 2020
• Anticipated Primary Completion Date: Oct 15, 2022
• Anticipated Study Completion Date: Mar 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group Each participant receives a customized probiotic based on the results of the test of their microbiota	Biological: Flore; personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Months to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona State University	Tempe	Arizona	United States	85287

Sponsors and Collaborators

• Arizona State University
• Sun Genomics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• link to official study ad

Publications

None provided.

• Responsible Party: James B Adams, President's Professor, Arizona State University
• ClinicalTrials.gov Identifier: NCT04655326
• Other Study ID Numbers: STUDY00012299
• First Posted: Dec 7, 2020
• Last Update Posted: Dec 30, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Results

No Results Posted as of Dec 30, 2021