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A Pilot Study to Explore the Role of Gut Flora in Fatty Liver

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: NCT04160949
Recruitment Status : Recruiting
First Posted : November 13, 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 regarding Fatty Liver.

Condition or disease Intervention/treatment
Fatty Liver Other: No Intervention

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 Fatty Liver.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Fatty Liver
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients
Patients who have been diagnosed with Fatty Liver.
 Other: No Intervention
There is no intervention for 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 ]
    The identification of bacterial species residing the gut flora will be processed by next generation sequencing followed by metagenomic analysis. Bacterial diversity will then be evaluated in parallel with relative abundance of targeted species within and among individual microbes.


Biospecimen Retention:   Samples With DNA
Stool Samples

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Fatty Liver
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)
  3. Diagnosis of fatty liver

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): NCT04160949


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

Locations
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United States, California
ProgenaBiome Recruiting
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    dfrsabinehazan@progenabiome.com   
Contact: Jordan Daniels, MS    805-339-0549    jordan@progenabiome.com   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators
ProgenaBiome
Investigators
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Principal Investigator: Sabine Hazan, MD ProgenaBiome
More Information
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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04160949    
Other Study ID Numbers: PRG-025
First Posted: November 13, 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
Plan Description: There is no plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Liver Diseases
Digestive System Diseases