Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Biological: Flore


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New client of Sun Genomics (has applied for testing and treatment, but not yet begun treatment) 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. Children and adults ages 2.5-75 years Exclusion Criteria: Antibiotic use in the last two months (not counting topical antibiotics) 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.

Ages Eligible for Study
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Minimum Age: 30 Months
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Each participant receives a customized probiotic based on the results of the measurement of their gut microbiota
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |