Clinical Trials for Lyme Disease

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Lyme Disease from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 25
• Active, not recruiting: 3
• Completed: 13
• Other: 9

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT00001539 — A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

This study will determine whether patients who have been infected with the Lyme bacteria, Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them and whether it is causing their symptoms. The information from this study may serve as a basis for developing stringent diagnostic criteria for Lyme disease and the establishment of future treatment trials.

Indivi…

NCT00028080 — Evaluation, Treatment, and Follow-up of Patients With Lyme Disease

This study is designed to establish a population of patients with Lyme disease for evaluation, treatment and follow-up to learn more about the infection.

Patients with active Lyme disease may be eligible for this study.

Participants will have a medical history and physical examination and diagnostic evaluations as appropriate to their individual condition. Laboratory tests may include routing…

NCT01793168 — Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford

CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups,…

NCT03337932 — Duration of Doxycycline Treatment in MEM Patients

The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.

NCT03462329 — Patient’s Pretreatment Expectations About Post-Lyme Symptoms

The investigators will focus on pretreatment expectations of patients with early Lyme disease manifested as erythema migrans with the aim of assessing the association between pretreatment expectations quantified with a questionnaire and treatment outcome quantified with the presence of post-Lyme symptoms. Furthermore, the investigators will compare the prevalence of nonspecific symptoms among p…

NCT03781700 — Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

Acute facial nerve palsy occur in 10-20/100 000 children/year in Sweden. About 20 % of these children will have persistent symptoms with excessive tear secretion, drooling and social problems due to asymmetry in the face. Studies on cortisone treatment to adult patients with acute facial nerve palsy have shown beneficial effects, but no studies with strong quality have been performed in childre…

NCT04402086 — Rheumatology Patient Registry and Biorepository

To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.

NCT05036707 — Human Immune Response to Ixodes Scapularis Tick Bites

Background:

Each year, the number of cases of tick-borne diseases increases. The deer tick (Ixodes scapularis) is the vector of at least 7 pathogens that cause human diseases, including Lyme disease. Researchers want to learn more to help them develop vaccines against ticks in the future.

Objective:

To learn how people s bodies, particularly the skin, respond to tick bites.

Eligibility:

He…

NCT05776251 — taVNS for Persistent Symptoms From Lyme Disease

This study is one of the first studies to investigate a non-antibiotic approach to the treatment of symptoms that persist after antibiotic treatment for Lyme disease (PTLS). Transcutaneous auricular vagus nerve stimulation (taVNS) offers the potential of being an effective and non-toxic approach to reduce the burden of multisystem symptoms in patients with PTLS. This study seeks to address an i…

NCT06026969 — Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

The purpose of this pilot study is to assess the feasibility of longitudinal neurodevelopmental evaluation of fetuses and infants exposed to Lyme disease in utero. Participants with Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) will be recruited during pregnancy. Pregnancies will be monitored and infant development will be assessed from birth until age 18 months.

NCT04806620 — Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research

The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyD…

NCT05641116 — Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.

Lyme borreliosis, commonly known as Lyme disease, has been clinically described for more than a century, but has been officially recognized for 40 years, with the detection of the Borrelia bacterium by W. Burgdorfer, in ticks of the Ixodes ricinus complex, identified a few years before.

NCT06397794 — Navigating Pregnancy and Parenthood With Lyme Disease

This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), and/or chronic Lyme (CL) either during or before a prior pregnancy. Participants will complete quantitative surveys on topics such as their medical history, th…

NCT06045416 — Borrelia B-cell Diagnostics

The investigators propose a single center, prospective observational study in children with Lyme disease (LD), the Borrelia B-cell diagnostics (BRILLIANT) study, to assess the immune response against Borrelia burgdorferi (Bb) with the following main objectives:

1. Development of Bb-specific ASC ELISpot as a new test method for diagnosis of early LD.

   There is an urgent unmet clinical need f…

NCT06655844 — Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

This study will investigate the effectiveness of the Sana Pain Reliever (Sana PR) at reducing chronic pain.

The Sana PR is a device comprised of one main component (Mask with Earbuds) and two ancillary components (Charger and Headband). The device is worn over the eyes (with earbuds in ears). The device pulses light at a single wavelength but various frequencies throughout a specific firmware …

NCT06511050 — Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

This will be a pilot multi-arm clinical trial investigating the feasibility of Lumbrokinase (LK) as an intervention in three clinical cohorts:

• Long Covid (LC)
• Post-treatment Lyme disease syndrome (PTLDS)
• Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

NCT06611111 — Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease

The goal of this clinical trial is to learn if an FDA approved drug, Ceftriaxone, given intermittently, can treat people between 18 and 75 years old with a history of Lyme disease, who are still experiencing persistent or returning symptoms after they have completed treatment. The main questions it aims to answer are:

• Will giving Ceftriaxone approximately every 5 days for 6 weeks be safe and…

NCT07335965 — Study of the Clinical, Microbiological and Epidemiological Characteristics of Recurrent Imported Borreliosis Confirmed by the CNR Borrelia

Recurrent borreliosis (RB) is a bacterial infection transmitted by ticks or lice. These infections occur in both temperate and tropical regions, but are rare in Australia and Antarctica. Due to climate change, the areas inhabited by the vectors of these infections are shifting, and the number of at-risk regions has significantly increased in recent years. More than twenty RB species have been d…

NCT06915324 — Transcranial Direct Current Stimulation for Post Treatment Lyme Disease

The primary purpose of this pilot study is to investigate a novel approach to the treatment of cognitive symptoms that persist despite prior antibiotic treatment for Lyme disease (Post treatment Lyme Disease or PTLD).

Aim 1: The primary aim of this study is to assess whether the processing speed of individuals with PTLD can be enhanced by combining transcranial direct current stimulation (tDCS…

NCT06451913 — Effect of Saccharomyces Boulardii CNCM I-745 on Gut Microbiota in Patients Undergoing Antibiotic Therapy (in the Context of Erythema Migrans (Early Skin Form of Lyme Borreliosis))

The aim of this study is to assess the effect of Saccharomyces boulardii CNCM I-745 on gut microbiota in patients undergoing antibiotic therapy (in the context of erythema migrans (early skin form of Lyme borreliosis)).

NCT07343089 — A Multicenter Real-life Study of Disseminated Borreliosis Cases Occurring in Patients Receiving Anti-CD20 Treatment in France

Clinical, biological, radiological, and pharmacological description of cases of disseminated borreliosis (Borrelia burgdorferi sl. and Borrelia miyamotoi) occurring in patients who received drug treatment based on anti-CD20 monoclonal antibodies.

NCT07562087 — A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure

This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.

NCT07500506 — A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine

The purpose of this study is to learn about the safety effects of the Lyme disease vaccine (called VLA15), and its ability to protect people from Lyme disease after a 5th dose of the vaccine.

This study is seeking participants who:

• are generally healthy and 7 years of age and older,
• have already been vaccinated with 4 doses of VLA15 (from the VALOR study), and have blood sample taken post…

NCT07561294 — A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)

This clinical study will evaluate the safety, reactogenicity, and immunogenicity of monovalent mRNA-1982, a messenger ribonucleic acid (mRNA) vaccine to prevent Lyme disease in healthy adults aged 18 to 70 years old.

NCT07683104 — Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders

Study Description:

This is a natural history protocol designed to characterize the clinical spectrum of trisomy 8 mosaicism and trisomy 8-associated autoinflammatory disease (TRIAD) and related autoinflammatory disorders and further evaluate approaches to screening, diagnosis, and management. We will enroll affected patients and their unaffected relatives and collect a variety of clinical data…

Active, Not Recruiting

NCT06731179 — A Prospective Study to Evaluate the Role of T-Cell Dysfunction in Patients Who Present Symptoms Associated With Long COVID, Lyme Disease and Myalic Encephalomyelitis / Chronic Fatigue Syndrome Using the Vira Immune Fluorospot T Cell Assay

This is a longitudinal observational study recruiting individuals that have attended three clinical sites with symptoms associated with a diagnosis of long COVID, PTLDS or ME/CFS. The study will be a multi-centre study, with up to 160 male and female participants enrolled. Participants that experience symptoms considered to be associated with a diagnosis of long COVID, PTLDS or ME/CFS will cons…

NCT06835075 — Clinicaly Manifested Reinfections with Borrelia Burgdorferi Sensu Lato

Data on reinfections with B. burgdorferi sensu lato in humans are scarce; they are limited to case reports and a few small groups of patients, mostly from the USA and less frequently from Europe. In these reports, the clinical manifestation of reinfection was usually erythema migrans and was most often documented after successful treatment of a previous infection (almost always erythema migrans…

NCT07226882 — A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults

The purpose of this study is to learn about the safety and effects of the Lyme disease vaccine (called VLA15) when given at different time points.

This study is seeking participants who:

• are generally healthy and between 18 and 44 years of age,
• have never had a vaccine for Lyme disease before,
• are not currently taking, or haven’t recently taken, medicines like chemotherapy, blood produc…

Not Yet Recruiting

NCT06859619 — Serological Measurement of Montpellier Professionals’ Contacts with Infectious Agents Responsible for Animal-borne Diseases

Zoonoses and arboviroses refer to a group of diseases transmitted from animals to humans, either directly or indirectly (via mosquitoes, ticks or contact with contaminated environments). Most of these diseases are found in certain tropical zones, but global warming and increased international trade are modifying their geographical distribution, with a gradual trend towards temperate regions. A …

NCT06929546 — Anti-phospolipid Antibodies in Lyme Borreliosis

Background Lyme borreliosis, caused by Borrelia burgdorferi sensu lato is transmitted to humans through the bite of an infected Ixodes tick. B. burgdorferi sensu lato accumulates intact phospholipids from its environment to support its growth. Several of these environmentally acquired phospholipids including phosphatidylserine, phosphatidylcholine and phosphatidic acid may be recognized by anti…

NCT06542289 — Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy

Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.

NCT07351721 — Borrelia Arthritis - a Hidden Cause of Arthritis in Danish Patients?

Why is this study being done? Borrelia arthritis is a joint infection caused by Borrelia bacteria transmitted by tick bites. It often affects the knee and can cause prolonged pain and swelling if not diagnosed and treated in time. While well recognized in North America, Borrelia arthritis is considered rare in Europe. Recent findings from the investigators in Denmark suggest it may be more comm…

NCT07230028 — Doxycycline Boosted Therapy in Lyme Borreliosis: DoBo Study.

The goal of this clinical trial is to learn if hydroxychloroquine works to treat long-term complaints attributed to Lyme borreliosis in adults. The main questions it aims to answer are:

Does addition of hydroxychloroquine reduce physical complaints? Researchers will compare hydroxychloroquine to a placebo (a look-alike substance that contains no drug) to see if hydroxychloroquine works to trea…

Completed Trials

NCT00237016 — Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

Abstract Background Tick-Borne Relapsing Fever (TBRF) is an acute febrile illness. In Israel, TBRF is caused by Borrelia persica and is transmitted by Ornithodoros tholozani ticks. We examined the safety and efficacy of a post exposure treatment policy to prevent TBRF.

Methods In a double blind, placebo controlled trial 93 healthy volunteers with suspected tick exposure (51 with bite signs and…

NCT00594997 — A School-Based Intervention to Reduce Lyme Disease

Our overall purpose of this study is evaluate whether a short in-class Lyme Disease education program based on social learning theory and the Health Belief Model can impact a child’s knowledge, attitude, and preventive behavior.

1. Deliver an educational program in schools to promote personal protective practices, encourage early disease detection and modify residential habitats to reduce tic…

NCT01143558 — Searching for Persistence of Infection in Lyme Disease

Background:

Lyme disease is an infection caused by Borrelia burgdorferi, a bacteria that is transmitted to humans by ticks. It can cause many different symptoms including rash, fever, headache, meningitis (infection of the central nervous system), and arthritis. While most patients improve after taking antibiotics, some patients continue to have symptoms. It is currently unknown why some patie…

NCT02414789 — Lyme Borreliosis and Early Cutaneous Diagnostic

Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with the early skin manifestation (erythema migrans).

This new proteomic method will be compared to the two existing method: culture of Borrelia and PCR detection of Borrelia (DNA detection of the bacteria).

NCT03891667 — Disulfiram: A Test of Symptom Reduction Among Patients With Previously Treated Lyme Disease

Approximately 10-20% of patients experience ongoing symptoms despite having received standard antibiotic therapy for Lyme disease. Possible explanations for persistent symptoms include persistent infection and/or post-infectious causes. Recent in vitro studies indicate that disulfiram is effective at killing both the actively replicating and the more quiescent persister forms of Borrelia burgdo…

NCT04801420 — Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population

VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary immunization schedules applying three (Month 0-2-6) or two (Month 0- 6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borrel…

NCT04938687 — Effect of Auricular Vagal Nerve Electrical Stimulation on Post-Treatment Lyme Disease Syndrome

This study is to assess if respiratory-gated auricular vagal nerve stimulation (RAVANS) can improve symptoms of post-treatment Lyme disease syndrome

NCT05305105 — Effects of Psilocybin in Post-Treatment Lyme Disease

This study will examine the effects of psilocybin on Lyme disease symptom burden and quality of life in people with Post-Treatment Lyme Disease (PTLD).

NCT05477524 — An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,400 healthy participants (this number excludes participants from 8 sites which were terminated for quality issues) 5 years and older will be recruited from areas with high levels of endemic Lyme disease to recei…

NCT05219929 — Tetracycline Treatment Tolerability Trial

Randomized, double-blind, placebo-controlled study (with a one-week washout period) where subjects receive either 3 months of tetracycline or 3 months of placebo. After the 3 month primary endpoint, in the follow-up period, patients will be assigned to the alternate treatment for 3 months with blind maintained.

NCT05634811 — Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children

This study is to understand if the study vaccine (called VLA15) is safe in healthy children.

We are looking for children who:

• are healthy
• are age 5 through 17
• have not been diagnosed with any form of Lyme disease in the past
• have not received any vaccines for Lyme disease in the past

Lyme disease happens most often in children of this age. The study vaccine may be used potentially to…

NCT05856812 — BOrrelia BUrgdorferi IN Children and Adolescents

The aim of this study is to assess B. burgdorferi antibodies in children and adolescents in north-western Switzerland and neighbouring countries (“Triregio”) treated at the University Children’s Hospital Basel to define age-dependent B. burgdorferi seroprevalence rates.

NCT05975099 — A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age

The purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult participants.

Other (Suspended)

NCT04031469 — A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

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

Other (Terminated)

NCT04038346 — Symptomatic Management of Lyme Arthritis

Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, but 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged arthritis symptoms and treatment courses. Excessive up-regulation of the inflammatory process has been shown in patients with antibiotic-refractory Lyme arthritis. The over-expressed pro-inflammatory cell mediators are dow…

Other (Withdrawn)

NCT04148222 — A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease

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

NCT06785402 — Ceftriaxone for Post-Treatment Lyme Disease

Lyme disease is a public health crisis in the US. It is estimated that over 400,000 cases occur every year with 10-20% of those infected going on to develop Post-Treatment Lyme disease Syndrome (PTLDS). The goal of this study is to investigate if giving Ceftriaxone every 5 days for about 6 weeks kills the organism that produces persistent Lyme infection.

Enrolled participants will be randomize…