New NIH Study on Parasitic Diseases

[Sadsack]

For anyone who shows a lot of the "parasitic" symptoms, this may be a great opportunity:

Host Response to Infection and Treatment in Filarial Diseases - Full Text View - ClinicalTrials.gov

Study 14 of 167 for search ofarasitic | Open Studies

Host Response to Infection and Treatment in Filarial Diseases
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), March 2009
First Received: November 3, 1999 Last Updated: April 15, 2009 History of Changes
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)ClinicalTrials.gov Identifier: NCT00001230

Purpose This study will evaluate and treat patients with filarial infections to explore in depth the immunology of the disease, including susceptibility to infection, disease development, and response to treatment. Filarial infections are caused by parasitic worms. The immature worm (larva) is transmitted to a person through a mosquito bite and grows in the human body to 2 to 4 inches in length. Although many of these infections do not produce symptoms, especially in the early stages of infection, others can have serious consequences, including swelling of the limbs or genitalia, allergic-lung problems, skin rash, eye inflammation that can lead to blindness, and heart disease. This protocol does not involve any experimental diagnostic procedures or treatments, and will use only procedures employed in the standard practice of medicine.
Persons between 1 and 75 years of age diagnosed with or suspected of infection with Wuchereria bancrofti, Bugia malayi, Onchocerca volvulus, Loa loa, or other parasitic worms may be eligible for this study.
Participants will have routine tests to determine the specific type of filarial infection. These may include special tests of the lungs, skin or heart, depending on the type of parasite suspected. Patients with skin reactions may have a "punch biopsy" to examine a small piece of affected skin. For this procedure, an area of skin is numbed with an anesthetic and a small circular area, about 1/3-inch in diameter and 1/2-inch thick, is removed using a sharp cookie cutter-type instrument. Some patients may require bronchoalveolar lavage.
For this procedure, the mouth and throat are numbed with lidocaine jelly and spray and, if needed, a sedative is given for comfort. A small plastic tube is placed in a vein to give medications. A pencil-thin tube is then passed through the nose or mouth into the lung airways to examine the airways. Salt water is injected through the bronchoscope into the air passage, acting as a rinse. A sample of the fluid is then withdrawn and examined for infection, inflammatory cells and inflammatory chemicals. (Bronchoalveolar lavage is done only if medically necessary and only on patients 21 years or older.) Once the diagnosis is established, standard treatment will be instituted with either diethylcarbamazine or ivermectin, depending on the type of infection.


Additional procedures for research purposes include:

• Extra blood draws to study immune cells and other immune substances. (This is the only research procedure that will be done in - More frequent and extensive follow-up evaluations than usual for routine care. They will include physical examination and blood studies.
• Urine collections at specified periods, possibly including 24-hour collections.
• Skin tests to examine the body's reaction to allergens-common environmental substances, such as cat dander or pollen-that cause an allergic reaction. The test is done in one of two ways: either the skin is lightly scratched and an allergen extract is placed over the just-broken skin, or a very fine needle is used to inject a small amount of allergen under the skin. In both methods, the site is monitored for swelling or hives in the next 48 hours.
• Leukapheresis (only on patients 21 or older ) to collect quantities of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body, either through the same needle or through another needle in the other arm.

Condition Filariasis

Helminthiasis
Loiasis
Mansonelliasis
Onchocerciasis

Study Type:ObservationalOfficial Title:Host Response to Infection and Treatment in the Filarial Diseases of Humans
Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:500Study Start Date:May 1988Detailed Description: Patients admitted on this protocol will have, or be suspected of having, one of the filarial infections affecting humans. After routine clinical evaluation they will be studied in depth immunologically, and their blood cells and/or serum will be collected to provide reagents (eg., specific antibodies, T-cell clones, etc.) that will be used in the laboratory to address the broader questions of diagnosis, immunoregulation, pathology and immunoprophylaxis. Careful observations of the patients' clinical and immunologic responses to therapy will be made, as well as long-term follow-up of these changes. It is anticipated both that the patients will receive optimal clinical care for their infections and that the specimens collected from them will prove to be valuable reagents for the laboratory studies of the immunologic responses unique to filarial or other related helminth infections.




Eligibility



Ages Eligible for Study: 1 Year to 75 YearsGenders Eligible for Study: BothAccepts Healthy Volunteers: NoCriteria

• INCLUSION CRITERIA:

Age 1-75 years.
Access to a primary medical care provider outside of the NIH.
Ability to give informed consent.


Therapeutic plasmapheresis or leukapheresis:

• individuals 18 years of age or older
• greater than 55 kgs with the objective of decreasing their filarial burden prior to treatment.

Research plasmapheresis or leukapheresis

• 18 years of age or older
• greater than 55 kgs.

EXCLUSION CRITERIA:
Pregnant or nursing women will be excluded from the treatment arm of the study.
Less than 1 year of age; greater than 75 years of age.


For research pheresis:

• No clinical contraindications to the procedure
• severe anemia
• cardiovascular disease
• coagulopathy

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001230

Contacts
Contact: Melissa A. Law, R.N.(301) 402-0265mlaw@niaid.nih.gov
Locations
United States, MarylandNational Institutes of Health Clinical Center, 9000 Rockville PikeRecruitingBethesda, Maryland, United States, 20892 Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)


More Information
Additional Information: NIH Clinical Center Detailed Web Page

Study ID Numbers:880083, 88-I-0083Study First Received:November 3, 1999Last Updated:April 15, 2009ClinicalTrials.gov Identifier:NCT00001230 History of Changes Health Authority:United States: Federal Government
Keywords provided by National Institutes of Health Clinical Center (CC): Wuchereria Bancrofti
Loa Loa
Brugia Malayi
Brugia Timori
Onchocerca Volvulus
Mansonella Perstans
Mansonella Ozzardi
Diethylcarbamazine (DEC)
Suramin
Ivermectin
Filarial Infection

Study placed in the following topic categories: Diethylcarbamazine
Skin Diseases
Onchocerciasis
Intestinal Volvulus
Suramin
Filariasis
Dipetalonema Infections
Loiasis
Nematode Infections
Skin Diseases, Infectious
Mansonelliasis
Ivermectin
Parasitic Diseases
Acanthocheilonemiasis
Helminthiasis

Additional relevant MeSH terms: Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases
Onchocerciasis
Filariasis
Loiasis
Nematode Infections
Infection
Spirurida Infections
Skin Diseases, Infectious
Mansonelliasis
Helminthiasis
Secernentea Infections

[Sadsack]

I am very surprised that this topic isn't getting more attention. It is totally free, and there are many parasites they are checking for. Inclusion criteria only has to be a SUSPICION of parasites. Ages 1 - 70, and they will also give free treatment if something is confirmed.

If I had any indication that parasites were a component of my "strain", I would be all over this.

It is one of the few things we can do that might yield objective information!

I know there are several regular posters who have lots of evidence of parasites. What would be your reason for not attempting to participate? NIH is VERY well funded, and you'd get far more medical attention here than you'd get at a doctor's office.

SS

[tcmgpt13]

It sounds as if a patient must already be diagnosed with a Filarial infection. Most doctors do not even test for any parasites in Morgellons patients as they are all sure there are no parasites involved as the folks they are seeing live in the US (or UK or other places free from parasites ). Then, in addition to this, the chances that the parasite samples sent in for testing by the few doctors who will test for parasites will be positive for any parasites at all is very questionable. How would a undiagnosed person who is undiagnosed with a Filarial disease get into this study? Also it is impractical logistically as unless someone lives close to Maryland individual participation would be costly.

"This study will evaluate and treat patients with filarial infections to explore in depth the immunology of the disease, including susceptibility to infection, disease development, and response to treatment.

Participants will have routine tests to determine the specific type of filarial infection."

There do not seem to be tests to determine if there is an infection in the first place. Participants would also need a doctor. Many (most) Morgellons patients do not have a doctor back home, at least one who will not laugh in their face. Many hide symptoms to get care for other problems. Who can blame them, given the current climate?

"Access to a primary medical care provider outside of the NIH."

[Sadsack]

It's not just filarial infections - there are 10 different parasitical infections. And there only has to be a SUSPICION, not proof. That is why they are going to do all the testing.

And with the pictures and samples that some on this site have accumulated, it is worth a shot.

I applied for the Undiagnosed Diseases study at the NIH last year, and received a letter saying that Morgellons is a diagnosis, and so I was not eligible. They suggested I apply for either the Rare Diseases program or the Parasitic Diseases program.

I received an email over the weekend about someone with Morgellons who applied for 4 different parasitic studies of the 10 available.

SS

[tcmgpt13]

The study title says the study is about:

Host Response to Infection and Treatment in Filarial Diseases

"Patients admitted on this protocol will have, or be suspected of having, one of the filarial infections affecting humans."

To be suspected of having a filarial infection one would still require a local doctor who suspects this type of infection (filarial). If the doctor has done a parasite test and it came back negative (not an uncommon result with parasite tests) then the patient would be dismissed by the doctor. Such patients would then have no necessary diagnosis (or suspicion of diagnosis) of filarial worms to participate in the study.

The other point, which also has not changed since my first post here, is the distance most people would have to travel to get to the NIH. Many do not have the money or feel well enough to travel.

In addition there are some of us who have already been using some of the medications, especially the ivermectin. So perhaps those of us who have used these medications feel that there might not be sufficient evidence left to find those parasites. Even untreated parasites are often difficult to diagnose with the currently available parasite tests most doctors employ in general practice.

[Jo]

Isnt it interesting how they've named most infections but not morgellons or myiasis.

Jo xxx

[Sadsack]

TCM -

You clearly have not taken the time to navigate the site. That is the page on just ONE of the studies. There are nine others.

You have such research skills...why don't you apply them to something that holds such promise instead of just knocking it?

SS

[tcmgpt13]

I am only commenting on what you posted here which was about this NIH study, the only one mentioned in your first post. You asked why no one was jumping up and down with joy and volunteering for the one NIH study you posted here. Why should I assume you also were talking about nine other studies on the NIH site? You did not mention that there were nine other studies so why would I even get on the NIH site since you posted about the one study in its entirety here on MDR? Why don't you try to be more clear next time you post instead of assuming people are mind readers?

What I said in no way knocks the NIH study(ies), but does explain why people may not be able to participate in the study(ies) which seemed to be your major concern in permalink 2 here. Having a doctor find or even suspect parasites before being accepted into the study(ies) in itself would be a large hurdle.

Permalink 6:

Originally Posted by Sadsack

TCM -

You clearly have not taken the time to navigate the site. That is the page on just ONE of the studies. There are nine others.

You have such research skills...why don't you apply them to something that holds such promise instead of just knocking it?

SS

Permalink 2:

Originally Posted by Sadsack

I am very surprised that this topic isn't getting more attention. It is totally free, and there are many parasites they are checking for. Inclusion criteria only has to be a SUSPICION of parasites. Ages 1 - 70, and they will also give free treatment if something is confirmed.

If I had any indication that parasites were a component of my "strain", I would be all over this.

It is one of the few things we can do that might yield objective information!

I know there are several regular posters who have lots of evidence of parasites. What would be your reason for not attempting to participate? NIH is VERY well funded, and you'd get far more medical attention here than you'd get at a doctor's office.

SS

[Sadsack]

This is boring.

[tcmgpt13]

Those who have nothing to say are usually easily bored.

Originally Posted by Sadsack

This is boring.