WithdrawnNot Applicable

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

Stopped: Company focus shifted

United States0Started 2020-03-02

Plain-language summary

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

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Correlation of Microbiome to Lyme Disease via Relative Abundance Found in Microbiome Sequencing

Timeframe: One year

NCT IDNCT04148222

SponsorProgenaBiome

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-03