MagicAcorn
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Evaluation of Lyme Disease: Clinical, Microbiological and Immunological Characteristics
This study is currently recruiting participants. Verified by National Institutes of Health Clinical Center (CC) March 2007 Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Information provided by: National Institutes of Health Clinical Center (CC) ClinicalTrials.gov Identifier: NCT00001539
Purpose
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.
Individuals in the following categories may be eligible for this study: chronic Lyme disease; chronic Lyme arthritis; seropositive control (are infected with the bacteria that causes Lyme disease but do not have disease symptoms); recovered control (have been sick with Lyme disease but were treated successfully and are currently well); control with multiple sclerosis (patients with multiple sclerosis); and healthy volunteers. Patients in the chronic Lyme disease category must be between 13 and 65 years of age; all others must be between 18 and 65 years of age. Candidates will be screened with blood and urine tests.
Participants will have a physical examination and the following tests:
Blood tests - Includes HLA-typing, a genetic test of immune system markers;
Leukapheresis - Collection of large numbers of white blood cells Whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through another needle in the other arm. (Alternatively, patients will 100 cc (about 7 tablespoons) of blood drawn.);
Lumbar puncture (spinal tap) - Collection of cerebrospinal fluid (CSF, fluid that bathes the brain and spinal cord). A local anesthetic is administered and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle;
Magnetic resonance imaging (MRI) of the brain - Imaging of the brain using a strong magnetic field and radio waves instead of X-rays. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member via an intercom at all times during the procedure;
Neuropsychologic testing;
Some participants may also have a hearing test and urine collection.
Participants whose test results are positive for Borrelia burgdorferi will be followed at NIH at intervals of 3 to 6 months until it is determined whether there is infection. Those who are infected will be offered treatment with the antibiotic ceftriaxone. Following treatment, patients will return to the NIH Clinical Center for follow-up visits 1 week after treatment and again at 3, 6 and 12 months. The lumbar puncture, hearing examination, blood and urine tests will be repeated at these visits to evaluate the response to treatment, and the leukapheresis will be repeated for research purposes. Patients whose MRI was abnormal during therapy will have a repeat MRI at the 3-month, 6-month and 1-year visits.
All participants with chronic Lyme disease, chronic Lyme arthritis, seropositive controls and recovered controls may be reevaluated at intervals of 6 to 12 months. Condition Chronic Disease Healthy Lyme Arthritis Lyme Disease Multiple Sclerosis
MedlinePlus related topics: Lyme Disease; Multiple Sclerosis
Study Type: Observational Study Design: Natural History
Official Title: A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Chronic Lyme Infection and Selected Control Populations Further study details as provided by National Institutes of Health Clinical Center (CC):
Total Enrollment: 440
Study start: March 1996 Lyme disease has emerged as the leading vector-borne disease in the United States. Despite how much has been learned about Lyme borreliosis in the past decade, there are still many remaining areas of uncertainty. One fundamental question is whether persistent signs and symptoms of disease, despite the administration of what is currently considered to be adequate antibiotic therapy, are due to ongoing active borrelial infection, to a post-infectious syndrome, to irreversible sequelae of earlier tissue injury or due to a condition unrelated to Lyme disease. Reliable objective markers of infection, of clinical status and of host responses to the organism are required to discern the scope and the implications of persistent borrelial infection, the effectiveness of current treatment options, and the development of new therapeutics approaches. The goal of this study is to assemble a well-characterized cohort of patients with presumed chronic Lyme disease and relevant controls that will yield a prospective database upon which stringent diagnostic criteria can be established and future therapeutic trials can be designed.
Eligibility Ages Eligible for Study: 13 Years and above, Genders Eligible for Study: Both
Accepts Healthy Volunteers Criteria
* INCLUSION CRITERIA:
Screening:
Age greater than or equal to 13 years old.
Suspect of suffering from Lyme disease.
Chronic/Post Lyme Disease (CLD): For the purposes of this study, CLD is defined as occurring in male or female patients age 13 and above who have been diagnosed with Lyme disease, have received recommended antibiotic therapy and have persistent symptoms and/or signs for at least six months after therapy. They also should have no other documented explanation for their signs and symptoms and have positive serum antibodies to B.burgdorferi confirmed by Western blot according to the CDC criteria (IgG immunoblot is considered positive if five of the following 10 bands are present: 18 kDa, 21 kDa (OspC), 28 kDa, 30 kDa, 39 kDa, 41 kDa (Fla), 45 kDa, 58 kDa (not GroEL), 66 kDa, and 93 kDa).
Lyme arthritis controls: For the purposes of this study, Lyme arthritis is defined as occurring in an otherwise healthy male or female aged 18 and above who had initial or intermittent episodes of arthritis involving one or few joints and have continuous joint swelling for more than three months, without any other cause being documented, and have positive serum antibodies to B.burgdorferi confirmed by Western blot according to the CDC criteria.
Recovered Controls: For the purposes of this study, a recovered control is defined as an otherwise healthy male or female aged 18 and above who has had Lyme disease, fulfilling the CDC Lyme Disease National Surveillance Case Definition and who had received accepted antibiotic treatment for Lyme disease (at least 3 months since the end of antibiotic therapy before protocol evaluation) and who are currently asymptomatic.
Seropositive Controls: For the purposes of this study, a serpositive control is defined as an otherwise healthy male or female aged 18 and above who has positive serum IgG antibody to B.burgdorferi by Western blot according to the CDC criteria and are asymptomatic and who recall no episodes of disease compatible with Lyme infection, and have not received antibiotic therapy for Lyme disease.
OspA vaccinated control: For the purposes of this study, a OspA vaccinated control is defined as an otherwise healthy male or female aged 18 and above who has received at least two doses of the OspA vaccine for Lyme disease (Lymerix). These controls may have a positive ELISA for B.burgdorferi but a negative (or unreadable) IgG western blot.
Multiple sclerosis controls: For the purposes of this study, a multiple sclerosis control is defined as an otherwise healthy male or female aged 18 and above with relapsing-remitting or progressive multiple sclerosis as defined by the Clinical Trial Committee of the National Multiple Sclerosis Society and no evidence of prior exposure to B.burgdorferi as indicate by negative history for Lyme disease and negative Western blot for B.burgdorferi in the serum by the CDC criteria. Patients should have a Kurtzke or Expanded Disability Status Scale (EDSS) between 1 to 5.
Healthy Volunteers: For the purpose of this study, a healthy volunteer is defined as healthy male or female, age 18 and above, with no history compatible with acute or chronic Lyme disease and negative western blot to B.burgdorferi in the serum by the CDC criteria.
EXCLUSION CRITERIA:
General exclusion criteria:
Age less than 18 (less than 13 for patients with chronic Lyme disease).
Weight less than 70 Lb (35 kg).
Pregnancy or lactation.
Women with childbearing potential who are sexually active and unwilling to use effective contraception.
Clinically significant laboratory abnormalities including positive test for syphilis (RPR), HBsAg, anti-HCV, anti-HIV.
Chronic medication use will be evaluated in a case-by-case basis.
Not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation.
Exclusion Criteria for Chronic Lyme Disease Patients And Lyme Arthritis Controls:
In addition to the general exclusion criteria, these individuals will be excluded for:
Use of immunosuppressive drugs such as systemic (but not topical or inhalant) steroids and cytotoxic agents.
History of any recognized autoimmune disease such as rheumatoid arthritis, vasculitis, systemic erythematous lupus, etc.
Serious pre-existing or concurrent chronic medical or psychiatric illnesses other than Lyme disease.
Past history of significant head trauma, alcohol or substance abuse in the past 5 years or other medical illness that might produce neurologic deficit (such as cerebrovascular disease).
Use of systemic antibiotics in the previous month.
Use of immunomodulators such as interferons.
Chronic medication use will be evaluated in a case-by-case basis.
Patients will be excluded from this protocol if they are judged by the principal investigator as having a significant impairment in their capacity for judgement and reasoning that compromise their ability to make decisions in their best interest.
Exclusion criteria for Recovered, Seropositive , OspA Vaccinated and Healthy Volunteers controls:
In addition to the above applicable exclusion criteria (general criteria and exclusion criteria for chronic Lyme disease patients and Lyme arthritis controls), these individuals will be excluded for:
Pre-existing or concurrent serious chronic medical or psychiatric illness.
Exclusion criteria for Multiple Sclerosis controls:
In addition to the above general exclusion criteria, these individuals will be excluded for:
Pre-existing or concurrent serious psychiatric or chronic medical illness besides Multiple Sclerosis.
Past history of significant head trauma, alcohol or substance abuse in the past 5 years or other medical illness, besides Multiple Sclerosis, that might produce neurologic deficit (such as cerebrovascular disease).
Previously received total lymphoid irradiation (TLI) or cladribine.
Has used of immunoactive medications (excluding beta-interferon) in the three months preceding the study.
In the three months prior to the study initiation, was given such investigational treatments as plasmapheresis, hyperbaric oxygen, gangliosides, Copolymer 1, etc.
Location and Contact Information Please refer to this study by ClinicalTrials.gov identifier NCT00001539
Patient Recruitment and Public Liaison Office (800) 411-1222 [email protected] TTY 1-866-411-1010
United States, Louisiana Tulane University, New Orleans, Louisiana, 70112-2699, United States; Recruiting
United States, Massachusetts New England Medical Center, Boston, Massachusetts, 02111, United States; Recruiting
United States, Minnesota Mayo Clinic, Rochester, Rochester, Minnesota, 55905, United States; Recruiting
United States, New York University Hospital at Stony Brook, Stony Brook, New York, 11794, United States; Recruiting
More Information
NIH Clinical Center Detailed Web Page
Publications
Steere AC, Malawista SE, Hardin JA, Ruddy S, Askenase W, Andiman WA. Erythema chronicum migrans and Lyme arthritis. The enlarging clinical spectrum. Ann Intern Med. 1977 Jun;86(6):685-98. Study ID Numbers: 960052; 96-I-0052 Last Updated: April 27, 2007 Record first received: November 3, 1999 ClinicalTrials.gov Identifier: NCT00001539 Health Authority: United States: Federal Government ClinicalTrials.gov processed this record on October 17, 2007
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MagicAcorn
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I think it interesting that they are suggesting Lyme and MS are the same thing.
I've thought that for years.
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CaliforniaLyme
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I think Megan Blewett proved it personally*)*)!
-------------------- There is no wealth but life. -John Ruskin
All truth goes through 3 stages: first it is ridiculed: then it is violently opposed: finally it is accepted as self evident. - Schopenhauer Posts: 5639 | From Aptos CA USA | Registered: Apr 2005
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map1131
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Western blot IgG positive only listed? Many chronic are very positive IgM. Am I misreading this study criteria?
Pam
-------------------- "Never, never, never, never, never give up" Winston Churchill Posts: 6478 | From Louisville, Ky | Registered: Jan 2002
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In other words, Lyme & MS may have the same root cause? If you agree with this line of thought, you should consider researching the Marshall Protocol since that is EXACTLY their thinking!
Posts: 246 | From Grass Valley, CA | Registered: Jun 2007
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This will be an important study, if it's done right. It does appear that the researchers want to see the differences/similarities of Lyme vs. MS, since they're including an MS control group.
I wonder who's going to conduct this study.
-------------------- The best index to a person's character is how he treats people who can't do him any good, and how he treats people who can't fight back. -Abigail van Buren (Pauline Esther Friedman) (1918-2002) Posts: 409 | From Florida | Registered: Dec 2005
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TerryK
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This looks like a sneaky way of including people who probably have lyme disease as controls so that they can manipulate the statistics.
I've heard for quite some time that MS patients are often lyme patients who have been misdiagnosed but I've no doubt that NONE of the IDSA ducks would admit that this is a possibillity even if they were informed enough to consider it.
Here is one example where they manipulated the meaning of the 41 band by including syphilis patients as controls.
http://en.wikipedia.org/wiki/Allen_Steere "Some physicians also criticize Steere for choosing to make 20% of his control -- 25 serum samples -- serum derived from syphilis patients. While this group formed 20% of the control, the disease's annual incidence in the United States is about 3 cases per 100,000 -- an incidence of far less, by a multiple of 300, than 1%.
This statistical manipulation dramatically impacted the importance of the 41 KdA band on blotting, because syphilis cross reacts with Lyme blots at 41 Kda due to their both possessing a key flagellar protein structure."
Maybe I'm being pessimistic but I will be very surprised if anything useful about the relationship between lyme and MS comes out of this. I think they will use this to manipulate the study results.
This statement is very scary to me given their propensity to manipulate studies to show what they want to show.
"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."
Then there is always the fact that they seem to be oblivious to co-infections, cysts and as someone else pointed out, the fact that IgG is not the best test to use for chronic lyme patients.
I would like to know who designed this study. That would speak volumes as to it's real purpose.
Our tax dollars at work.
Terry
Posts: 6286 | From Oregon | Registered: Jan 2006
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Vermont_Lymie
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I agree with Terry's points. Seeing that they are including people with MS as controls, doesn't that bias the study, as some/many or all of these MS controls may actually have lyme?
You normally would not want the same disease to be present in your treated population AND your controls. Odd.
Also, they do not mention or totally ignore the reality of the lyme co-infections that many of their "chronic" study enrollees will have. How could this be that they miss the existence of the many co-infections that come along with borrelia in ticks in the US, which often cause similar neurological symptoms to lyme?
Bias indeed, and problematic for the goals of the study, which as a result of missing the range of co-infections may well conclude that anyone still symptomatic after a couple of weeks of IV ceftriaxone has "post-lyme" syndrome due to tissue damage....
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TerryK
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Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Ahhhh.....this explains it. As far as I've ever been able to tell, they are IDSA cronies.
Terry
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TerryK
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I missed the part where the Study start is March 1996. Did this study really start in 1996 and if so what was the outcome??
"Study start: March 1996"
Terry
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MagicAcorn
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Terry K said:
I missed the part where the Study start is March 1996. Did this study really start in 1996 and if so what was the outcome??
Terry they are still doing the trials and are recruiting.
This study is currently recruiting participants. Verified by National Institutes of Health Clinical Center (CC) March 2007
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I don't know guys. I'm a firm believer that many multiple sclerosis patients actually have Lyme disease but nothing has been proven yet. However, there are a lot of studies that's strongly point to it.
Dr. Steven Phillips gave a presentation on MS and it's connection to Lyme. He presented a ton of studies. If you're interested, you can get the DVD of his presentation at the following link (FYI: I have no affiliations whatsoever with this group): Dr Phillips dvd
I assume that the MS patients in this study will have had to test negative for Lyme or never have been diagnosed with Lyme disease.
If some of the MS patients end up testing positive for Lyme during this research, THAT will be an interesting piece of data. It'll at least show that MS may be an infectious disease versus an autoimmune disease. It'll also show how bad Lyme testing is.
If the MS patients' symptoms improve, that'll be an interesting find for them too.
Keep in mind that the NIH funded Dr. Fallon's study. Guys, I'm just trying hard here to think positive! I really hope that whoever conducts this study has no hidden agenda and wants the truth...whether it's in our favor or not.
And band 41 is really not a significant band by itself. It's the least specific for Lyme. Band 41 represents the flagella for the genus Borrelia and the genus Treponema (syphilis belongs in this family).
BUT, yes I can see how someone can easily manipulate the data to support their view. I'm going to try and be positive about this and pray that someone honest is lined up to do this study.
Ok, I'm functioning on little sleep here and I'm SO sorry if what came out is all gibberish!
-------------------- The best index to a person's character is how he treats people who can't do him any good, and how he treats people who can't fight back. -Abigail van Buren (Pauline Esther Friedman) (1918-2002) Posts: 409 | From Florida | Registered: Dec 2005
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dmc
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I will ask Dr. P. about this Mon. He was at conference this past week. I do not trust any "data" or study collected by that "camp".
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daise
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Hi,
I agree. I'm very leery of this study. Are there interests of MS pharmaceutical companies at work here? They stand to lose a whole lot of their profits--big time profits--if Lyme is proved to cause some cases of MS. I can't help but think this study may be motivated by profits, not peoples health.
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