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

• Sponsor: ProgenaBiome (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04100616
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 40
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Overweight or Obesity; Obesity; Obesity, Morbid; Obesity, Abdominal; Obesity; Familial; Obesity; Endocrine; Obesity, Visceral; Obesity Hypoventilation Syndrome	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, particularly regarding obesity.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated 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 Obesity
• Actual Study Start Date: Mar 2, 2020
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Obsese individuals Patients with a BMI greater than or equal to 30	Other: No intervention; There is no intervention for this study

Outcome Measures

Primary Outcome Measures

1. Correlation of Microbiome to Obesity via Relative Abundance Found in Microbiome Sequencing [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

Secondary Outcome Measures

1. Validation of Sequencing Methods [1 year]

   To validate the methods used to sequence samples

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProgenaBiome	Ventura	California	United States	93003

Sponsors and Collaborators

• ProgenaBiome

Investigators

• Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ProgenaBiome
• ClinicalTrials.gov Identifier: NCT04100616
• Other Study ID Numbers: PRG-005
• First Posted: Sep 24, 2019
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Obesity, Morbid; Obesity, Abdominal; Overweight

Study Results

No Results Posted as of Sep 5, 2021