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A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04031469
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

Study Description
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Brief Summary:
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Condition or disease Intervention/treatment
Gut Microbiome Gastrointestinal Microbiome Other: There is no intervention in this study

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
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Other
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : July 10, 2023
Estimated Study Completion Date : December 10, 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
General Population
The general population will have their microbiome sequenced from stool samples provided.
 Other: There is no intervention in this study
There is no intervention in this study


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Validation of Sequencing Methods [ Time Frame: One year ]
    To validate the methods used to sequence samples


Biospecimen Retention:   Samples With DNA
Stool samples.

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults and minors of any age
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031469


Contacts
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Contact: Sabine Hazan, MD 18053390549 drsabinehazan@progenabiome.com
Contact: Jordan E Daniels, MS 18053390549 jordan@progenabiome.com

Locations
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United States, California
Sabine Hazan Recruiting
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    drsabinehazan@progenabiome.com   
Contact: Jordan Daniels, MS    8053390549    jordan@progenabiome.com   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators
ProgenaBiome
Investigators
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Study Director: Sabine Hazan, MD ProgenaBiome
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04031469    
Other Study ID Numbers: PRG-002
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ProgenaBiome:
Microbiome