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WithdrawnNCT04148222Updated Jun 5, 2025

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

An observational study in Lyme Disease and Lyme Disease, Chronic, sponsored by ProgenaBiome. Withdrawn at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by ProgenaBiome · Observational

Why this study was withdrawn
Company focus shifted
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Lyme Disease
  • Lyme Disease, Chronic
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In context

Lyme Disease

91 studies on the registry are indexed under Lyme Disease; 27 are open to participants now.

Browse Lyme Disease studies →

Lead sponsor

ProgenaBiome is the lead sponsor of 47 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a diagnosis of Lyme Disease

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients

    Patients who have been diagnosed with Lyme Disease

    Other: No intervention

Interventions

  • OtherNo intervention

    There is no intervention for this study

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: One year

Secondary outcomes

  1. Validation of Sequencing Methods

    To validate the methods used to sequence samples

    Time frame: One year

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Study locations

1 site
  • ProgenaBiome
    Ventura, California 93003, United States
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References and documents

Individual participant data

Plan to share: No — There is no plan to share IPD.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04148222
Lead sponsor
ProgenaBiome
Responsible party
Sponsor
First posted
Nov 1, 2019
Start date
Mar 2, 2020
Primary completion
Mar 2030 (estimated)
Completion
Jul 2030 (estimated)
Last update
Jun 5, 2025

Study contacts

Sabine Hazan, MD
principal investigator · ProgenaBiome

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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