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Home > "P" Clinical Trials Conditions > Parasitic Infections of the Gastrointestinal Tract  Parasitic Infections of the Gastrointestinal Tract
Parasitic Infections of the Gastrointestinal Tract
For Condition: Amebiasis,Cryptosporidiosis,Giardiasis,Parasitic Disease,Parasitic Intestinal Disease
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 200
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 770094; 77-I-0094
Study Start Date: May 23, 1977
Record last reviewed: April 8, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001162
Other Parasitic Disease Studies:
1. Parasitic Infections of the Gastrointestinal Tract
Related Studies:
Other Parasitic Disease Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Parasitic Infections of the Gastrointestinal Tract
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