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

Withdrawn before enrolling

Conditions studied: Lyme Disease, Lyme Disease, Chronic

In brief

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

Key facts

Study ID

NCT04148222

Run by

ProgenaBiome

People needed

0

Starts

2020-03-02

Expected to finish

2030-07-01

Last updated by the study team

2025-06-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ProgenaBiome — Ventura, California, United States

Full record on ClinicalTrials.gov

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