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Parasitic Infections of the Gastrointestinal Tract

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Amebiasis
+3

+ Cryptosporidiosis
+ Giardiasis
Over 3 Years
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: May 1977

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: May 23, 1977Actual date on which the first participant was enrolled.

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. 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.

Official TitleStudy of Patients With Parasitic Infections of the Gastrointestinal Tract 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
150 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Case-only
These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 3 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Amebiasis
Cryptosporidiosis
Giardiasis
Parasitic Disease
Parasitic Intestinal Disease
Gastrointestinal Helminth Infections
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, United StatesSee the location

SuspendedOne Study Center
Parasitic Infections of the Gastrointestinal Tract | PatLynk