Lyme DiseaseNCT04148222
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease
An observational study of Lyme Disease and Lyme Disease, Chronic, run by ProgenaBiome at 1 site in United States.
Trial summary
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Lyme Disease Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lyme Disease, Lyme Disease, Chronic
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2020to Jul 2030
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a diagnosis of Lyme Disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Lyme Disease, Lyme Disease, Chronic
- Being tested
- No intervention
- Medical subject headings
- Lyme Disease, Post-Lyme Disease Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention for this study
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who have been diagnosed with Lyme Disease Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (1)
Validation of Sequencing Methods
To validate the methods used to sequence samples
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start2 Mar 2020
- Primary completionMar 2030 (estimated)
- Study completionJul 2030 (estimated)
Why it stopped: Company focus shifted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProgenaBiome
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Hazan, MD, Principal investigator, ProgenaBiome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148222
- Sponsor's protocol ID
- PRG-019
- Status last verified
- Sep 2021
- First submitted
- 30 Oct 2019
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease
- ClinicalTrials.gov ID
- NCT04148222
- Acronym / sponsor ID
- PRG-019
- Conditions
- Lyme Disease, Lyme Disease, Chronic
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Company focus shifted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ProgenaBiomeUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Lyme Disease
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: No interventionPatients who have been diagnosed with Lyme Disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of Lyme Disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention for this study | Other | Patients |
Primary outcome
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.
1 secondary outcome
Validation of Sequencing Methods
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Hazan, MD principal investigator
ProgenaBiome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Disease and Lyme Disease, Chronic, run by ProgenaBiome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Microbiome to Lyme Disease via Relative Abundance Found in Microbiome Sequencing (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.