Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

NCT04655326 | Completed Results

• 1 other identifier: STUDY00012299
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Parent Global Impressions of Autism - Change

  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).

  change in score between baseline and 3 months

Secondary Outcomes (2)

• Social Responsiveness Scale

  change in score between baseline and 3 months

• Gastrointestinal Symptom Rating Scale

  change in score between baseline and 3 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Dietary Supplement: Flore

Interventions

Flore DIETARY_SUPPLEMENT

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

Treatment Group

Eligibility Criteria

• Age: 30 Months - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Genomics: collaborator
• Arizona State University: lead

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287, United States

Location

Related Links

• link to official study ad

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

crataegus extract

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Prof. James Adams
• Organization: Arizona State University

jim.adams@asu.edu

480 965 3316

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President's Professor

Model Details: Each participant receives a customized probiotic based on the results of the measurement of their gut microbiota

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: October 15, 2020
• Primary Completion: May 15, 2025
• Study Completion: July 12, 2025
• Last Updated: April 9, 2026
• Results First Posted: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)