AutismNCT04100863
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism
An observational study of Autism and Autism Spectrum Disorder, run by ProgenaBiome at 1 site in United States.
Trial summary
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Autism, Autism Spectrum Disorder, Autistic Disorder
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2020to Jun 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals ages 6 and older who have been diagnosed with Autism
Who may be able to join
- Signed informed consent by parent or legally authorized representative
- Male or female patients age 6 and older.
- Diagnosis of autism per DSM-V criteria (See appendix)
Who cannot join
- Refusal by parent or legally authorized representative to sign informed consent form
- Treatment with antibiotics within 2 weeks prior to screening
- Treatment with probiotics within 6 weeks prior to screening
- History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- Postoperative stoma, ostomy, or ileoanal pouch
- Participation in any experimental drug protocol within the past 12 weeks
Show all 9Show fewer
- Treatment with total parenteral nutrition
- Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
- Inability of parent or legally authorized representative to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism.
Read the detailed description
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding autism.
- Conditions
- Autism, Autism Spectrum Disorder, Autistic Disorder, Autism, Akinetic, Autism; Atypical, Autism; Psychopathy
- Being tested
- No Intervention
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Akinetic Mutism, Antisocial Personality Disorder, Fragile X Syndrome, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
There is no intervention for this study.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Autism | Individuals who have been diagnosed with autism Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Microbiome to Autism via Relative Abundance Found in Microbiome Sequencing
Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific Autism Spectrum Disorders
Measured: 1 year
Secondary outcomes (1)
Validation of Sequencing Methods
To validate the methods used to sequence samples
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start2 Mar 2020
- Primary completionMar 2030 (estimated)
- Study completionJun 2030 (estimated)
Why it stopped: Company focus shifted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- ProgenaBiome
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Hazan, MD, Principal investigator, ProgenaBiome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100863
- Sponsor's protocol ID
- PRG-006
- Status last verified
- Jun 2025
- First submitted
- 20 Sep 2019
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only aggregated and deidentified data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism
- ClinicalTrials.gov ID
- NCT04100863
- Acronym / sponsor ID
- PRG-006
- Conditions
- Autism, Autism Spectrum Disorder, Autistic Disorder, Autism, Akinetic, Autism; Atypical, Autism; Psychopathy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Company focus shifted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ProgenaBiomeUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism.
Detailed description
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding autism.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with Autism | – | Other: No InterventionIndividuals who have been diagnosed with autism |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals ages 6 and older who have been diagnosed with Autism
Key inclusion criteria (3 listed)
- Signed informed consent by parent or legally authorized representative
- Male or female patients age 6 and older.
- Diagnosis of autism per DSM-V criteria (See appendix)
Key exclusion criteria (9 listed)
- Refusal by parent or legally authorized representative to sign informed consent form
- Treatment with antibiotics within 2 weeks prior to screening
- Treatment with probiotics within 6 weeks prior to screening
- History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- Postoperative stoma, ostomy, or ileoanal pouch
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 |
|---|---|---|
| No InterventionThere is no intervention for this study. | Other | Individuals with Autism |
Primary outcome
Correlation of Microbiome to Autism via Relative Abundance Found in Microbiome Sequencing
Time frame: 1 year
Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific Autism Spectrum Disorders
1 secondary outcome
Validation of Sequencing Methods
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: Undecided. Only aggregated and deidentified data will be shared with other researchers.
Related trials for Autism
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
RecruitingPhase 2
TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
Autism Disorder
Not yet recruitingObservational study
EEG As a Genetic Selection Lever in Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
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.
Sabine Hazan, MD principal investigator
ProgenaBiome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Autism Spectrum Disorder, run by ProgenaBiome 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 9 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: withdrawn, as of the sponsor's last update on 5 Jun 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Correlation of Microbiome to Autism via Relative Abundance Found in Microbiome Sequencing (time frame: 1 year). 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 5 Jun 2025.