NCT04655326

Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: Arizona State University · Academic / Other
• Sex: All
• Age: 30 Months – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Flore	personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals

Timeline

• Start date: 2020-10-15
• Primary completion: 2025-05-15
• Completion: 2025-07-12
• First posted: 2020-12-07
• Last updated: 2026-04-09
• Results posted: 2026-04-09

Locations

1 site across 1 country: United States