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Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT04655326
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : December 7, 2020
Sponsor:
Collaborator:
Sun Genomics
Information provided by (Responsible Party):
James B Adams, Arizona State University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : October 15, 2020
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : March 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Parent Global Impressions of Autism [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   30 Months to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655326


Contacts
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Contact: James B. Adams, PhD 480 965 3316 jim.adams@asu.edu
Contact: Devon Coleman, BS 480 965 5071 devon.coleman@asu.edu

Locations
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United States, Arizona
Arizona State University Recruiting
Tempe, Arizona, United States, 85287
Contact: James B Adams, PhD    480-965-3316    jim.adams@asu.edu   
Contact: Devon Coleman, BS    480 965 5071    devon.coleman@asu.edu   
Sponsors and Collaborators
Arizona State University
Sun Genomics
More Information
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Additional Information:

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Responsible Party: James B Adams, President's Professor, Arizona State University
ClinicalTrials.gov Identifier: NCT04655326    
Other Study ID Numbers: STUDY00012299
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders