A Pilot Study to Explore the Role of Gut Flora in Elevated Cholesterol

• Conditions: Elevated Cholesterol; Cholesterol, Elevated
• Interventions: Other: No Intervention

• Registration Number: NCT04148339
• Lead Sponsor: ProgenaBiome

Brief Summary

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

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 regarding Elevated Cholesterol.

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-11-01
• Study Start: 2020-03-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05
• Primary Completion: 2023-03
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers).
3. LDL>100
4. Total Cholesterol>200

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
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	No Intervention	Patients with Elevated Cholesterol

Primary Outcome Measures

Name	Time	Method
Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing	One 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 specific disease types.

Secondary Outcome Measures

Name	Time	Method
Validation of Sequencing Methods	One year	To validate the methods used to sequence samples

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States