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

ProgenaBiome1 site in 1 country100 target enrollmentMarch 2, 2020

ConditionsOverweight and Obesity Overweight or Obesity Obesity Obesity, Morbid Obesity, Abdominal Obesity; Familial Obesity; Endocrine Obesity, Visceral Obesity Hypoventilation Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Overweight and Obesity
Sponsor: ProgenaBiome
Enrollment: 100
Locations: 1
Primary Endpoint: Correlation of Microbiome to Obesity via Relative Abundance Found in Microbiome Sequencing
Status: Withdrawn
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2, 2020

End Date

July 2030

Last Updated

11 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

ProgenaBiome

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Refusal by patient to sign informed consent form
•Treatment with antibiotics within two weeks prior to screening
•Treatment with probiotics within six weeks prior to screening
•History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy
•Postoperative stoma, ostomy, or ileoanal pouch
•Participation in any experimental drug protocol within the past 12 weeks
•Treatment with total parenteral nutrition
•Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
•Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Outcomes

Primary Outcomes

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