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Protocol Details

Study of Patients with Parasitic Infections of the Gastrointestinal Tract

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

77-I-0094

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: N/A
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Giardia;
Helminth;
Cryptosporidium;
Hookworms;
Trichuris;
Strongyloides;
Protozoa;
Small Bowel Biopsy;
E. Histolytica;
Duodenal Aspiration

Recruitment Keyword(s)

Parasitic Disease;
Amebiasis;
Tapeworm;
Trichinosis;
Gastrointestinal Trematodes;
Clonorchis;
Opisthorchis;
Coccidiosis;
Paragonimiasis;
Echinococcus

Condition(s)

Amebiasis;
Cryptosporidiosis;
Giardiasis;
Parasitic Disease;
Parasitic Intestinal Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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Eligibility

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 older than 2.

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.


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Citations:

The mechanisms of giardia lamblia differentiation into cysts

Cholesterol starvation induces differentiation of the intestinal parasite giardia lamblia

Chronic giardiasis: studies on drug-sensitivity, toxin production and host immune response

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Contacts:

Principal Investigator

Referral Contact

For more information:

Theodore E. Nash, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
BG 4 RM 424
4 MEMORIAL DR
BETHESDA MD 20814
(301) 496-6920
tnash@niaid.nih.gov

Amara G. Pabon, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 9N224A
10 Center Drive
Bethesda, Maryland 20892
(301) 402-7823
pabona@mail.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00001162

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