Trial | NCT04655326  Report issue

Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Intervention/Treatment

    Flore

  • Study Participants

    1000
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.
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 Started
Oct 15
2020
Primary Completion
Oct 15
2023
Anticipated
Study Completion
Oct 15
2023
Anticipated
Last Update
Jan 09
2023

Biological Flore

personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals

Treatment Group Experimental

Each participant receives a customized probiotic based on the results of the test of their microbiota

Criteria 

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.
No Results Posted