Parasitic Infections of the Gastrointestinal Tract
| Status: | Terminated |
|---|---|
| Conditions: | Infectious Disease, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 3 - Any |
| Updated: | 6/3/2017 |
| Start Date: | May 23, 1977 |
| End Date: | May 31, 2017 |
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.
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 standard of 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.
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 standard of 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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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