Parasitic Infections of the Gastrointestinal Tract
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|ClinicalTrials.gov Identifier: NCT00001162|
Recruitment Status : Terminated
First Posted : November 4, 1999
Last Update Posted : July 2, 2017
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.
|Condition or disease|
|Amebiasis Cryptosporidiosis Giardiasis Parasitic Disease Parasitic Intestinal Disease Gastrointestinal Helminth Infections|
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||Study of Patients With Parasitic Infections of the Gastrointestinal Tract|
|Study Start Date :||May 23, 1977|
|Study Completion Date :||May 31, 2017|
- To Collect and study different parasite populations to study and/or axenization of specific parasites, analyze immune responses to homologous or heterologous parasites, and the development of diagnostic tests [ Time Frame: Screening visit ]
- Off label use of FDA approved drugs for treatment of Giardiasis in patients who cannot be cured otherwise, determining empirically which regimen is effective and safe [ Time Frame: Post Tx follow up visit ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001162
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Theodore E Nash, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|