Probiotic Therapy for Children and Adults With Autism Spectrum Disorder
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
350 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Devon Coleman, BS; James B. Adams, PhD
Data sourced from clinicaltrials.gov
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