Study 1 of 3 for search of: "Giardiasis"
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Parasitic Infections of the Gastrointestinal Tract
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), March 2008
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001162
  Purpose

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
Amebiasis
Cryptosporidiosis
Giardiasis
Parasitic Disease
Parasitic Intestinal Disease

MedlinePlus related topics: Cryptosporidiosis Giardia Infections Parasitic Diseases
U.S. FDA Resources
Study Type: Observational
Official Title: Study of Patients With Parasitic Infections of the Gastrointestinal Tract

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 200
Study Start Date: May 1977
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001162

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 770094, 77-I-0094
Study First Received: November 3, 1999
Last Updated: July 18, 2008
ClinicalTrials.gov Identifier: NCT00001162  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Giardia
Helminth
Cryptosporidium
Hookworms
Trichuris
Strongyloides
Protozoa
Small Bowel Biopsy
E. Histolytica
Duodenal Aspiration
Parasitic Disease
Amebiasis
Tapeworm
Trichinosis
Gastrointestinal Trematodes
Clonorchis
Opisthorchis
Coccidiosis
Paragonimiasis
Echinococcus

Study placed in the following topic categories:
Protozoan Infections
Gastrointestinal Diseases
Hydatidosis
Giardiasis
Intestinal Diseases
Ancylostoma duodenale
Echinococcosis
Amebiasis
Cryptosporidiosis
Digestive System Diseases
Hookworm Infections
Parasitic Diseases
Intestinal Diseases, Parasitic
Helminthiasis

Additional relevant MeSH terms:
Coccidiosis
Sarcodina Infections
Mastigophora Infections
Parasitic Diseases, Animal
Protozoan Infections, Animal
Sarcomastigophora Infections

ClinicalTrials.gov processed this record on January 16, 2009