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Parasitic Infections of the Gastrointestinal Tract
This study is currently recruiting participants.
Study NCT00001162   Information provided by National Institutes of Health Clinical Center (CC)
First Received: November 3, 1999   Last Updated: August 24, 2009   History of Changes

November 3, 1999
August 24, 2009
May 1977
May 1980   (final data collection date for primary outcome measure)
 
Determine the feasibility of using PET scanning methodologies with sestamibi.
Complete list of historical versions of study NCT00001162 on ClinicalTrials.gov Archive Site
 
Evaluate Pgp reversal in patients receiving the Pgp antagonist tariquidar.
 
Parasitic Infections of the Gastrointestinal Tract
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 the normal and usual medical 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.

 
Observational
 
  • Amebiasis
  • Cryptosporidiosis
  • Giardiasis
  • Parasitic Disease
  • Parasitic Intestinal Disease
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
 
May 1980   (final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:

Persons with proven or highly suspected parasitic infections involving the gastrointestinal tract (including amebiasis, giardiasis, hookworm, strongyloidiasis, trichuriasis, pinworm, tapeworm, cyclorsporiasis, cryptosporidia infections, microsporidia infections, isosporidium infections, trichinosis, gastrointestinal dwelling trematodes, coccdioiosis, and echinococccus and additional infections).

Persons of all ages.

Ability and willingness of the subject or legal guardian/representative to give written informed consent.

EXCLUSION CRITERIA:

Subject unwilling or unable to comply with requirements of the protocol in the opinion of the investigator.

Both
 
No
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010
United States
 
NCT00001162
 
770094, 77-I-0094
National Institute of Allergy and Infectious Diseases (NIAID)
 
 
National Institutes of Health Clinical Center (CC)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP