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Large-Scale Study Will Seek to Unearth Causes of Persistent Symptoms of Lyme Disease

Tufts University researchers have received a $20.7 million grant from the National Institutes of Health (NIH) to try to answer some of the most vexing questions around chronic Lyme disease. The collaborative team will lead the largest NIH-funded prospective study to date, following patients from their earliest diagnosis of Lyme disease in order to better identify why some people go on to develop debilitating symptoms later on.

While Lyme disease often resolves with a two-to-three-week course of antibiotics, some patients see symptoms persist for months or years. Despite decades of research, many of the fundamentals of post-treatment Lyme disease syndrome or chronic Lyme disease remain elusive. There is no diagnostic test, clear definition, or specific treatment. There is no agreement on the mechanisms causing the condition or how frequently it occurs. It’s even difficult to calculate the number of cases. This is because symptoms such as fatigue, muscle pain, and cognitive impairments are similar to those reported for other conditions, including the flu, fibromyalgia, chronic fatigue syndrome, and long COVID. 

The researchers believe that identifying patients at their earliest diagnosis of Lyme disease and following them for over one year could shed light on why some return to good health and others develop prolonged symptoms. The study will aim to enroll 1,000 people with acute Lyme disease at suburban and rural community health centers and practices in Lyme-disease-endemic areas in New England over five years. 

The research team is led by Linden Hu, an infectious disease specialist and the Paul and Elaine Chervinsky Professor in Immunology at Tufts University School of Medicine who is an internationally recognized leader in the field of Lyme research. For nearly half a century, researchers from Tufts University and its affiliated teaching hospitals have been involved in many of the field’s seminal discoveries and are currently engaged in multiple avenues of ongoing investigation into the cause, prevention, and potential cure of Lyme and other tick-borne diseases.

“The underlying causes of chronic illnesses postinfection remain largely unknown because there isn’t something you can point to on a test to find what’s causing them. But people are tired, their muscles ache, and they can’t think clearly, so we know something is happening, we just can’t quantify it,” said Hu, who is also co-director of the Tufts Lyme Disease Initiative. “When we start with patients we know have Lyme disease, we can cast a wide net to try to find what’s causing these persistent symptoms.”

The multicentered team from Tufts School of Medicine, Cummings School of Veterinary Medicine at Tufts University, Northwestern Feinberg School of Medicine, MaineHealth, Massachusetts General Hospital, and the Tufts Medicine health system comprises clinicians, epidemiologists, immunologists, microbiologists, and statisticians with a deep understanding of Lyme disease. The team’s hypothesis is that chronic Lyme disease is the result of a confluence of events including the genetics of the patient, the infecting bacteria, and prior infections with other organisms that could result in epigenetic changes that alter immune responses. This complexity may contribute to why chronic Lyme disease has been so difficult to understand.

“This initiative provides a phenomenal opportunity to generate new insights into the diverse outcomes of Lyme disease that will provide improved means of diagnosis, prevention, and treatment,” said Helen Boucher, dean of Tufts School of Medicine and chief academic officer at Tufts Medicine. “This study from bench to bedside to community is the collaboration that scientists, physicians, and patients need in order to gain an understanding of this complicated disease.”

“It’s part of the Tufts mission to help find solutions to national and global challenges,” said Bernard Arulanandam, vice provost for research at Tufts. “This project can have a far-reaching impact, particularly as Lyme disease in the U.S. expands beyond New England due to a convergence of factors. As the burden of Lyme disease has increased, and as we’ve seen the impact of postinfection syndromes, this project is timely and much needed.”

As part of the work, the team will develop one of the largest and best characterized specimen banks that will be shared with the research community, providing an unparalleled resource for future studies.

Smaller studies of people with chronic Lyme disease have produced confounding results. Hu says that a large study approaching the condition from the complementary perspectives of the epidemiology, immunology, and microbiology of the disease is what is needed to move the field forward.

“Science and medicine’s understanding of postinfection Lyme disease has been stuck at the same place for more than 30 years. Long COVID has brought attention to infection-associated chronic illnesses, but it has also made these conditions more difficult to study because so many people have had COVID,” said Hu. “We hope that by having these leaders in the field working together to try to solve this in an integrative and multidisciplinary approach that we will finally be able to offer our patients some answers and eventually some cures.”

This work is supported by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases under award number P01AI181934. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.