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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04148222
Other study ID # PRG-019
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

Clinical Trial Summary

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


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 Lyme Disease


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 N/A and older
Eligibility 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. Diagnosis of Lyme Disease 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


Related Conditions & MeSH terms


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 Lyme Disease 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 specific disease types. One year
Secondary Validation of Sequencing Methods To validate the methods used to sequence samples One year
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