NCT00001162

Parasitic Infections of the Gastrointestinal Tract

Terminated Last updated 2 July 2017

What this trial tests

trial in Amebiasis in 150 participants. Terminated before completion.

Timeline

23 May 1977

31 May 2017

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	150
Start date	23 May 1977
Estimated completion	31 May 2017
Sites	1 location across United States

Conditions studied

• Amebiasis — all drugs for Amebiasis →
• Cryptosporidiosis — all drugs for Cryptosporidiosis →
• Giardiasis — all drugs for Giardiasis →
• Parasitic Disease — all drugs for Parasitic Disease →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

3 and older, any sex, with Amebiasis or Cryptosporidiosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.