Cryptosporidiosis Clinical Trial
Official title:
Study of Patients With Parasitic Infections of the Gastrointestinal Tract
This protocol offers diagnosis and standard medical treatment for various parasitic
gastrointestinal infections. Gastrointestinal parasites are either worms (helminths) or
one-celled animals called protozoans which live in the human intestines. Often, parasitic
infections do not cause illness. In these cases, drug treatment is not indicated, because
treatment can have adverse side effects. Patients will be examined for their immune
responses, correlation between the number of parasites and disease, and other studies.
Individuals with known or suspected parasitic diseases of the gastrointestinal tract,
including amebiasis, giardiasis, hookworm, strongyloidiasis, trichuriasis, pinworm, tapeworm,
trichinosis, clonorchis, opisthorchis, coccidiosis, paragonimiasis, and echinococcus may be
eligible for this study.
Patient evaluations may include blood and urine tests, stool examination, X-rays, ultrasound
studies and, uncommonly, duodenal aspiration for examination of fluid from the duodenum
(first part of the small intestine). Other tests may be required, depending on the parasite
and disease. Direct examination of the tissues of the intestines may be required to rule out
certain infections.
Research procedures include collection of stool, blood and duodenal fluid when the diagnosis
has been established and these procedures are not required for medical care. Patients with
strongyloidiasis may also be given a diagnostic skin test similar to skin tests for
tuberculosis and allergies. Research procedures on children will be limited to collection of
stool, urine and blood. No more than 7 milliliters (1 1/2 teaspoons) per kilogram (2.2
pounds) body weight of blood will be collected in children over a 6-week period. In adults no
more than 30 tablespoons of blood will be collected in a 6-week period.
Parasites may fail to respond to treatment. In these cases, it may be necessary to grow the
parasite in the laboratory in order to test treatments in the test tube. Patients who do not
respond to standard medications and dosing may need different doses of drugs or drugs or
combinations of drugs used in the United States for other medical problems. If these
medications or doses are used, patients will be informed of their possible side effects.
The precis of this protocol is to allow the evaluation, treatment and study of patients with a variety of gastrointestinal parasites. This protocol primarily allows evaluation and treatment of patients with any intestinal parasite that requires a medical evaluation. The treatment and evaluation consists of standard of care. Research aspects include the collection and study of different parasite populations, analysis of the immune responses of the host, a correlation between parasite burden in the host and disease. These patients also serve as a source of reagents such as feces, white blood cells, and serum. The off-label use of FDA approved drugs is employed to treat symptomatic giardiasis in patients who cannot be cured otherwise and to determine empirically which regimens are effective and safe. ;
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