Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001162
Status:
TERMINATED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Parasitic Infections of the Gastrointestinal Tract
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Study of Patients With Parasitic Infections of the Gastrointestinal Tract
Status:
TERMINATED
Status Verified Date:
2017-05-31
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 12 teaspoons per kilogram 22 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
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 12 teaspoons per kilogram 22 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
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 77-I-0094 | None | None | None |