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

P

ProgenaBiome

Status

Unknown

Conditions

Cholesterol, Elevated
Elevated Cholesterol

Treatments

Other: No Intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04148339
PRG-022

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Volunteers

No 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

Trial design

100 participants in 1 patient group

Patients
Description:
Patients with Elevated Cholesterol
Treatment:
Other: No Intervention

Trial contacts and locations

1

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Central trial contact

Sabine Hazan, MD; Jordan Daniels, MS

Data sourced from clinicaltrials.gov

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