Clinical Trial of Xenodiagnosis After Antibiotic Treatment for Lyme Disease

Lyme disease is the most common
vector-borne disease in the United States it is caused by the bacteria
Borrelia burgdorferi and is transmitted to humans by ticks. While most patients
improve after taking antibiotics, it is currently not known why some patients
continue to have symptoms like fatigue, musculoskeletal pain, and cognitive
complaints, a condition called post-treatment Lyme disease syndrome or PTLDS for short. A concern has been that the symptoms of post-treatment Lyme
disease syndrome may represent persistent infection with the bacteria
that causes Lyme disease. In this clinical trial researchers use a
procedure called xenodiagnosis to see if clean laboratory-reared ticks can be
used to detect the B burgdorferi bacteria in people who have Lyme disease and received antibiotic treatment and if it correlates with persistent symptoms.
The results could help understand patients with persistent symptoms and
offer researchers a new tool with which to study the mechanism of disease. The
research study is a collaborative effort with teams at the National Institute of
Allergy and Infectious Diseases (NIAID), a part of the National Institutes of
Health in Bethesda Maryland, Tufts University in Boston, Massachusetts,
Mansfield family practice in Mansfield Connecticut, and New York Medical College in Valhalla, New York. The research study team will review an informed
consent form with interested participants and answer any questions.
After agreeing to participate in the study a clinical physical exam will be
performed and medical history will be taken. Blood will be drawn for Lyme
disease tests. “My wife discovered the bull’s eye rash on a rear part of my body.
I went to an urgent care and they checked me out and then I followed up my primary
care physician and she took blood and found out that I tested positive for Lyme and she
said I may want to check NIH – they have a clinical trial
going on. I went online and contacted them and then they contacted me and said they’d like to use me in the trial.” “This is one of the most friendly staffs
of physicians and assistants that I’ve ever experienced anywhere. Very good
people and everyone in general is really accommodating. It’s tough to get
into this place, but once you’re in everyone treats you well.” The first step
in the xenodiagnosis procedure is tick placement. The ticks used in this study
are larval (or juvenile ticks) that have just hatched and have not fed on any
other animal. The ticks have tested negative for all known diseases that can
be transmitted to humans. Up to 30 ticks will be placed. Whenever possible
the ticks are applied close to the site of the participant’s Lyme disease
presentation while still being convenient. The ticks are secured with
adhesive mesh over and around the ticks to keep them in place. The ticks will be
placed on the participants’ bodies for several days, during which time
participants will have to keep the area dry and keep a diary card to track any
symptoms. If participants develop any discomfort during this time or wish to
discontinue the study for any reason the study team can be contacted and the
ticks will be removed. “I found it rather fascinating to watch these little
creatures really consume me for four or five days. Watching through a little
window and I thought it was very interesting because this hopefully will
determine what’s going on with Lyme disease.” If participants are eligible and
agreed to it they may undergo skin biopsies at the site where the ticks
were placed. A local anesthetic is injected into the biopsy site and two
small pieces of skin (a punch biopsy) will be taken. The site will heal without
sutures in most cases. The second step in the xenodiagnosis procedure is tick
removal. During this visit the mesh will be removed and the ticks
will be collected. If some ticks are still attached the participant may be
asked to return in a few days to have them removed. The procedure has been well tolerated. The most commonly reported symptom has been a little itching at the
tick feeding sites. After the ticks are removed the study team will call the
participants to make sure they are not having any problems. Participants will be
asked to fill out a diary card for one month and watch for any new symptoms.
Participants will return for follow-up visits at one and three months after
removal of the ticks. If needed, follow-up visits may be conducted by phone. “These
are some of the tiny little larvae that were placed on my body. They were sealed up by a bandage. None of them escaped and more than half of them found me to be a
nice host and plumped up quite nicely. I never felt them at all. I never had any
itching. I didn’t even know they were there. So I recommend anybody try it.” The study team will discuss the
xenodiagnosis results with the participants when they become available.
All samples will be stored to help researchers learn more about Lyme
disease or related conditions. Thank you for your interest in Lyme disease
research studies sponsored by NIH. If you would like to know more about this and
other studies please visit and search “Lyme disease studies.”

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