Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04100616
Other study ID # PRG-005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 2, 2020
Est. completion date July 2023

Study information

Verified date September 2021
Source ProgenaBiome
Contact Sabine Hazan, MD
Phone 18053390549
Email drsabinehazan@progenabiome.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding obesity.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
No intervention
There is no intervention for this study

Locations

Country Name City State
United States ProgenaBiome Ventura California

Sponsors (1)

Lead Sponsor Collaborator
ProgenaBiome

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of Microbiome to Obesity via Relative Abundance Found in Microbiome Sequencing 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 1 year
Secondary Validation of Sequencing Methods To validate the methods used to sequence samples 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2