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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04148339

Enrollment

Registered

2019-11-01

Start date

2020-03-02

Completion date

2030-07-31

Last updated

2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholesterol, Elevated, Elevated Cholesterol

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.

Interventions

OTHERNo Intervention

There is no intervention for this study.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Validation of Sequencing Methods	One year	To validate the methods used to sequence samples

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026