Autism Spectrum DisorderNCT04655326
Probiotic Therapy for Children and Adults With Autism Spectrum Disorder
A study testing Flore in people with Autism Spectrum Disorder, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 months to 75 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Flore
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 12 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Customized 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.
Read the 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
- Being tested
- Flore
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloreDietary supplement
personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Each participant receives a customized probiotic based on the results of the test of their microbiota Receives: Dietary Supplement: Flore |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: change in score between baseline and 3 months
Secondary outcomes (2)
Social Responsiveness Scale
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.
Measured: change in score between baseline and 3 months
Gastrointestinal Symptom Rating Scale
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
Measured: change in score between baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start15 Oct 2020
- Primary completion15 May 2025
- Study completion12 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant receives a customized probiotic based on the results of the measurement of their gut microbiota
- Masking
- None (open label)
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Genomics
- Responsible party
- Principal investigator, James B Adams, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655326
- Sponsor's protocol ID
- STUDY00012299
- Status last verified
- Mar 2026
- First submitted
- 30 Nov 2020
- Last updated
- 9 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Customized Probiotic Therapy for Children and Adults With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04655326
- Acronym / sponsor ID
- STUDY00012299
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Sun Genomics
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 12 Jul 2025 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Posted 9 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant receives a customized probiotic based on the results of the measurement of their gut microbiota
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: FloreEach participant receives a customized probiotic based on the results of the test of their microbiota |
Who may qualify
- Ages
- 30 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Florepersonalized blend of GRAS approved probiotic strains, prebiotics, and botanicals | Dietary supplement | Treatment Group |
Primary outcome
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).
2 secondary outcomes
Social Responsiveness Scale
Time frame: change in score between baseline and 3 months
Gastrointestinal Symptom Rating Scale
Time frame: change in score between baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- link to official study adLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flore in people with Autism Spectrum Disorder, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Global Impressions of Autism - Change (time frame: change in score between baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.