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Completed

NCT Number: NCT04655326

Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

30 month–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Tempe, Arizona, 85287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flore

Dietary Supplement

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

Primary outcomes

  1. Parent Global Impressions of Autism - Change

    Time frame: change in score between baseline and 3 months

    The PGIA-Change assesses the change in 20 different autism-related symptoms on a 7-point scale, from -3 (much worse) to 0 (no change) to +3 (much better)

    Note that this is a different scale than the PGIA-Baseline, which assesses severity on an absolute scale. The rationale for the two scales is that, based on our clinical experience, it appears that parents can give an approximate value for their child's severity (PGIA-Baseline), but that it is more accurate to ask them about change (with the PGIA-Change) than to ask them about severity again and compare it vs a baseline score (PGIA-Baseline).

Secondary outcomes

  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). We report the average score of those 15 items

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Sun Genomics

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 7, 2020
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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