A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease
NCT ID: NCT04031469
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
1000 participants
OBSERVATIONAL
2019-07-11
2030-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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General Population
The general population will have their microbiome sequenced from stool samples provided.
There is no intervention in this study
There is no intervention in this study
Interventions
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There is no intervention in this study
There is no intervention in this study
Eligibility Criteria
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Inclusion Criteria
* 2\. Male or female patients of any age (interest is given to children to compare with mothers).
Exclusion Criteria
* 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
12 Years
ALL
Yes
Sponsors
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ProgenaBiome
OTHER
Responsible Party
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Principal Investigators
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Sabine Hazan, MD
Role: STUDY_DIRECTOR
ProgenaBiome
Locations
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Sabine Hazan
Ventura, California, United States
Countries
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References
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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.
Other Identifiers
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PRG-002
Identifier Type: -
Identifier Source: org_study_id
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