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Probiotics for Autism

Phase < 1
Waitlist Available
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children and adults ages 2.5-75 years
Screening 3 weeks
Treatment Varies
Follow Up change in score between baseline and 3 months
Awards & highlights


This trial looks at whether a probiotic can help improve symptoms in children and adults with autism, as well as any gastrointestinal issues they may have.

Who is the study for?
This trial is for children and adults aged 2.5-75 years who have been diagnosed with Autism Spectrum Disorder (ASD). Participants must be new clients of Sun Genomics, not having started treatment yet, and their ASD diagnosis will be confirmed by an evaluation. They should not have had any medication or therapy changes in the last two months nor plan to change them during the first three months of the study.Check my eligibility
What is being tested?
The study is testing a customized probiotic called Flore on individuals with autism to see if it can improve both autism-related symptoms and gastrointestinal issues. The participants' responses to this probiotic therapy are being closely monitored.See study design
What are the potential side effects?
While specific side effects are not listed, probiotics typically may cause digestive discomfort initially such as gas or bloating; however, they're generally considered safe. Any unexpected reactions would be documented throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am between the ages of 2.5 and 75 years old.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in score between baseline and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in score between baseline and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Parent Global Impressions of Autism
Secondary outcome measures
Gastrointestinal Symptom Rating Scale
Social Responsiveness Scale

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Each participant receives a customized probiotic based on the results of the test of their microbiota

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Probiotics, a common treatment for Autism Spectrum Disorder (ASD), work by modulating the gut microbiota. This modulation can improve gastrointestinal symptoms, which are frequently observed in ASD patients. Additionally, altering the gut microbiota can impact the gut-brain axis, potentially reducing core ASD symptoms such as social-affective behaviors. These improvements are significant for ASD patients as they can enhance overall quality of life and adaptive functioning.
Effects of gut microbial-based treatments on gut microbiota, behavioral symptoms, and gastrointestinal symptoms in children with autism spectrum disorder: A systematic review.Effects of Probiotic Supplementation on Gastrointestinal, Sensory and Core Symptoms in Autism Spectrum Disorders: A Randomized Controlled Trial.Role of Probiotics in Managing Gastrointestinal Dysfunction in Children with Autism Spectrum Disorder: An Update for Practitioners.

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor
288 Previous Clinical Trials
108,961 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
383 Patients Enrolled for Autism Spectrum Disorder
Sun GenomicsUNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Flore (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04655326 — Phase < 1
Autism Spectrum Disorder Research Study Groups: Treatment Group
Autism Spectrum Disorder Clinical Trial 2023: Flore Highlights & Side Effects. Trial Name: NCT04655326 — Phase < 1
Flore (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04655326 — Phase < 1
~0 spots leftby Aug 2024