- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04148222
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease
September 2, 2021 updated by: ProgenaBiome
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Lyme Disease
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Lyme Disease
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Ventura, California, United States, 93003
- Recruiting
- ProgenaBiome
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with a diagnosis of Lyme Disease
Description
Inclusion Criteria:
- Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
- Male or female patients of any age (interest is given to children to compare with mothers)
- Diagnosis of Lyme Disease
Exclusion Criteria:
- Refusal to sign informed consent form
- History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
- Postoperative stoma, ostomy, or ileoanal pouch
- Participation in any experimental drug protocol within the past 12 weeks
- Treatment with total parenteral nutrition
- Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
- Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
Patients who have been diagnosed with Lyme Disease
|
There is no intervention for this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of Microbiome to Lyme Disease via Relative Abundance Found in Microbiome Sequencing
Time Frame: 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.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validation of Sequencing Methods
Time Frame: One year
|
To validate the methods used to sequence samples
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2020
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
July 1, 2023
Study Registration Dates
First Submitted
October 30, 2019
First Submitted That Met QC Criteria
October 30, 2019
First Posted (Actual)
November 1, 2019
Study Record Updates
Last Update Posted (Actual)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 2, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRG-019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is no plan to share IPD.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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