Gut MicrobiomeNCT04031469
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease
An observational study of Gut Microbiome and Gastrointestinal Microbiome, 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Gastrointestinal Microbiome, Autism
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 10 Dec 2030
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults and minors of any age
Who may be able to join
- 1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
- 2. Male or female patients of any age (interest is given to children to compare with mothers).
Who cannot join
- 1. Refusal to sign informed consent form
- 2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- 3. Postoperative stoma, ostomy, or ileoanal pouch
- 4. Participation in any experimental drug protocol within the past 12 weeks
- 5. Treatment with total parenteral nutrition
- 6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
- 7. Inability 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.
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.
- Conditions
- Gut Microbiome, Gastrointestinal Microbiome, Autism, Autism Spectrum Disorder, Autism Spectrum Disorder High-Functioning, Alzheimer Disease
- Being tested
- There is no intervention in this study
- Keywords
- Microbiome, autism, ASD, Myalgic encephalomyelitis, ME/CFS, Psoriasis, Chronic UTI, Chronic Urinary Tract Infection, Ulcerative Colitis, UC, Multiple Sclerosis, MS, Chronic Constipation, Constipation, Celiac disease, Celic Sprue, Lyme disease, Elevated Cholesterol, Colorectal Cancer, Cancer
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Alzheimer Disease, Crohn Disease, Fatigue Syndrome, Chronic, Psoriasis, Colitis, Ulcerative, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention in this studyOther
There is no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| General Population | The general population will have their microbiome sequenced from stool samples provided. Receives: Other: There is no intervention in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Microbiome to Disease 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 gastrointestinal disease types.
Measured: One year
Secondary outcomes (1)
Validation of Sequencing Methods
To validate the methods used to sequence samples
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start11 Jul 2019
- Primary completion10 Jul 2030 (estimated)
- Study completion10 Dec 2030 (estimated)
Why it stopped: Administrative
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiomeStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProgenaBiome
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Hazan, MD, Study director, ProgenaBiome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031469
- Sponsor's protocol ID
- PRG-002
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2019
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hazan S, Stollman N, Bozkurt HS, Dave S, Papoutsis AJ, Daniels J, Barrows BD, Quigley EM, Borody TJ. Lost microbes of COVID-19: Bifidobacterium, Faecalibacterium depletion and decreased microbiome diversity associated with SARS-CoV-2 infection severity. BMJ Open Gastroenterol. 2022 Apr;9(1):e000871. doi: 10.1136/bmjgast-2022-000871.
PubMed 35483736
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. 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 Disease
- ClinicalTrials.gov ID
- NCT04031469
- Acronym / sponsor ID
- PRG-002
- Conditions
- Gut Microbiome, Gastrointestinal Microbiome, Autism, Autism Spectrum Disorder, Autism Spectrum Disorder High-Functioning, Alzheimer Disease
- Keywords
- Microbiome, autism, ASD, Myalgic encephalomyelitis, ME/CFS, Psoriasis, Chronic UTI, Chronic Urinary Tract Infection
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Administrative
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- ProgenaBiomeUniversity, hospital or other
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 10 Jul 2030 (estimated)
- Study completion
- 10 Dec 2030 (estimated)
- First posted
- 24 Jul 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Population | – | Other: There is no intervention in this studyThe general population will have their microbiome sequenced from stool samples provided. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and minors of any age
Key inclusion criteria (2 listed)
- 1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
- 2. Male or female patients of any age (interest is given to children to compare with mothers).
Key exclusion criteria (7 listed)
- 1. Refusal to sign informed consent form
- 2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- 3. Postoperative stoma, ostomy, or ileoanal pouch
- 4. Participation in any experimental drug protocol within the past 12 weeks
- 5. Treatment with total parenteral nutrition
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 |
|---|---|---|
| There is no intervention in this studyThere is no intervention in this study | Other | General Population |
Primary outcome
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
Time frame: One 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 gastrointestinal disease types.
1 secondary outcome
Validation of Sequencing Methods
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 35483736Hazan S, Stollman N, Bozkurt HS, Dave S, Papoutsis AJ, Daniels J, Barrows BD, Quigley EM, Borody TJ. Lost microbes of COVID-19: Bifidobacterium, Faecalibacterium depletion and decreased microbiome diversity associated with SARS-CoV-2 infection severity. BMJ Open Gastroenterol. 2022 Apr;9(1):e000871. doi: 10.1136/bmjgast-2022-000871.
- Individual participant dataSharing planned: No
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Microbiome
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 study director
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 Gut Microbiome and Gastrointestinal Microbiome, 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 2 inclusion and 7 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: paused, as of the sponsor's last update on 21 Sep 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?
Results are not available in the source record.
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 Disease via Relative Abundance Found in Microbiome Sequencing (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04031469, which also lists 1 linked publication.
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 21 Sep 2026.