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A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04148222
Recruitment Status : Not yet recruiting
First Posted : November 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

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

Condition or disease Intervention/treatment
Lyme Disease Lyme Disease, Chronic Other: No intervention

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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Group/Cohort Intervention/treatment
Patients
Patients who have been diagnosed with Lyme Disease
Other: No intervention
There is no intervention for this study




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Validation of Sequencing Methods [ Time Frame: One year ]
    To validate the methods used to sequence samples


Biospecimen Retention:   Samples With DNA
Stool Samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of Lyme Disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04148222


Contacts
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Contact: Sabine Hazan, MD 8053390549 sabinehazan@aim.com
Contact: Jordan Daniels, MS 8053390549 msjordandaniels@gmail.com

Locations
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United States, California
ProgenaBiome
Ventura, California, United States, 93003
Sponsors and Collaborators
ProgenaBiome

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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04148222     History of Changes
Other Study ID Numbers: ProgenaBiome-019
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lyme Disease
Post-Lyme Disease Syndrome
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections