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

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ClinicalTrials.gov Identifier: NCT04213651
Recruitment Status : Recruiting
First Posted : December 30, 2019
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

Tracking Information
First Submitted Date December 23, 2019
First Posted Date December 30, 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: December 27, 2019)		 Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing [ Time Frame: Three years ]
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 with diabetes mellitus
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
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 Diabetes Mellitus
Official Title A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus
Brief Summary 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 diabetes mellitus
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Stool samples
Sampling Method Non-Probability Sample
Study Population Patients with diabetes mellitus
Condition
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
Intervention Other: No intervention
There is no intervention for this study
Study Groups/Cohorts Diabetes Mellitus
Patients with diabetes mellitus
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 27, 2019)		 100
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, demonstrating that the patient understands the procedures required for the study and the purpose of the study

    a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent

  2. Male or female of all ages
  3. Diagnosis of diabetes mellitus based on blood glucose and/or hemoglobin A1C

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Sabine Hazan, MD 18053390549 drsabinehazan@progenabiome.com
Contact: Jordan Daniels, MS 18053390549 jordan@progenabiome.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04213651
Other Study ID Numbers PRG-032
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: No
Plan Description: There is no plan to share IPD.
Current Responsible Party ProgenaBiome
Original Responsible Party Same as current
Current Study Sponsor ProgenaBiome
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Sabine Hazan, MD ProgenaBiome
PRS Account ProgenaBiome
Verification Date September 2021