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

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. Identifier: NCT04100616
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : September 5, 2021
Information provided by (Responsible Party):

Tracking Information
First Submitted Date September 20, 2019
First Posted Date September 24, 2019
Last Update Posted Date September 5, 2021
Actual Study Start Date March 2, 2020
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 20, 2019)
Correlation of Microbiome to Obesity 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 obesity types
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 20, 2019)
Validation of Sequencing Methods [ Time Frame: 1 year ]
To validate the methods used to sequence samples
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obesity
Official Title A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obesity
Brief Summary This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding obesity.
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, particularly regarding obesity.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples With DNA
Stool from patients.
Sampling Method Probability Sample
Study Population Adults 18 years of age and older with a BMI greater than or equal to 30
  • Overweight and Obesity
  • Overweight or Obesity
  • Obesity
  • Obesity, Morbid
  • Obesity, Abdominal
  • Obesity; Familial
  • Obesity; Endocrine
  • Obesity, Visceral
  • Obesity Hypoventilation Syndrome
Intervention Other: No intervention
There is no intervention for this study
Study Groups/Cohorts Obsese individuals
Patients with a BMI greater than or equal to 30
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 20, 2019)
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Signed informed consent by patient
  2. Male or female patients age 18 and older.
  3. Diagnosis of obesity based on Body Mass Index (BMI) of 30 or greater.

Exclusion Criteria:

  1. Refusal by patient to sign informed consent form
  2. Treatment with antibiotics within two weeks prior to screening
  3. Treatment with probiotics within six weeks prior to screening
  4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy
  5. Postoperative stoma, ostomy, or ileoanal pouch
  6. Participation in any experimental drug protocol within the past 12 weeks
  7. Treatment with total parenteral nutrition
  8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
  9. Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: Sabine Hazan, MD 18053390549
Contact: Jordan Daniels, MS 18053390549
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT04100616
Other Study ID Numbers PRG-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Only aggregated, deidentified data will be made available to other researchers.
Responsible Party ProgenaBiome
Study Sponsor ProgenaBiome
Collaborators Not Provided
Principal Investigator: Sabine Hazan, MD ProgenaBiome
PRS Account ProgenaBiome
Verification Date September 2021