Chronic Lyme gut microbiome study reopens enrollment
(Update May 3) Once again, the Lyme community has responded enthusiastically to the opportunity to help develop a new test for chronic Lyme disease. The reopened enrollment is now closed. We’ll keep you informed about the study’s progress.
Last month, we sent out a special announcement about researchers working to develop a diagnostic test for chronic Lyme disease.
They were seeking participants in a study of how chronic Lyme disease affects the gut’s microbiome.
Response from the Lyme community was overwhelming. Within 12 hours, every slot in the study was filled! We had to tell people that enrollment was closed and shut down our application link.
However, because of that enthusiastic response, Flightpath Biosciences, the company conducting the study, applied for regulatory approval to expand the number of participants.
They obtained that approval and have reopened applications for their “Study of a Potential Test for Persistent Lyme Disease.”
Can gut microbes predict chronic Lyme disease?
Here’s a recap of information we originally posted last month:
Recent research by Professor Kim Lewis, of Boston’s Northeastern University, has shown that changes in the bacteria in a person’s gastrointestinal tract may be predictive of late-stage Lyme disease.
In general, bacteria in the gut are a good indicator of our overall health. These bacteria strongly influence our immune system, and in some cases, our microbiomes may be as important as our genetics in predicting diseases.
In consultation with Professor Lewis and building on his work, Flightpath Biosciences plans to study blood and stool samples from chronic Lyme patients and compare them to those of healthy people.
They’ll be looking for biomarkers—objective signs that are distinctive to chronic Lyme disease. If found, these biomarkers could lead to a new way of diagnosing the disease and demonstrating its active presence in patients.
One of the biggest barriers for chronic Lyme disease patients has been the lack of a test that can detect on-going disease. The company’s new study and related research could hold the key to finally developing an accurate test and potentially new treatments.
Requirements
That’s where you come in. If you are willing to take part in this research, the requirements for participating in the study criteria are below.
To be eligible, you must be:
- 18 years of age or older
- A resident of the United States
- Previously diagnosed with Lyme disease, and
- Have persistent symptoms six months or more after receiving first treatment with antibiotics.
Participants:
- Must be willing to stop and avoid antibiotics for two weeks prior to sample collection,
- Will provide information in a brief questionnaire, and
- Will provide a blood and stool sample from home or in some cases at a local designated facility.
Those who complete the study will receive a $50 Amazon gift card.
When you apply to take part, you’ll be asked to fill out a survey with questions about your health history, including what medications you are taking or have taken in the past.
If you meet the criteria, a stool sample kit will be sent to you, with instructions on how to collect and submit it.
Then, a phlebotomist will schedule a visit with you to draw your blood sample. At that point, you are done with the process, and you’ll be sent your Amazon card.
Enrollment goals have been reached. Applications are closed.
LymeDisease.org is providing this information from Flightpath Biosciences as part of our mission to accelerate research in Lyme disease. One question the company hopes to answer is whether there are differences between the microbiomes or blood samples of males and females in this population. So, while this study is re-opening to all genders, if you know of a male with persistent Lyme disease, please encourage them to enroll.
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