Suspended

Study of Patients With 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

Animal Diseases+23

+ Digestive System Diseases

+ Gastrointestinal Diseases

Over 3 Years
See all eligibility criteria
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
See protocol details

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, 1977

Actual date on which the first participant was enrolled.

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.

NCT00001162
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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 3 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Animal DiseasesDigestive System DiseasesGastrointestinal DiseasesHelminthiasisInfectionsIntestinal DiseasesNematode InfectionsParasitic Diseases, AnimalProtozoan InfectionsProtozoan Infections, AnimalTrematode InfectionsAdenophorea InfectionsEnoplida InfectionsSecernentea InfectionsStrongylida InfectionsAmebiasisCestode InfectionsCoccidiosisCryptosporidiosisEchinococcosisGiardiasisHookworm InfectionsIntestinal Diseases, ParasiticParagonimiasisParasitic DiseasesTrichinellosis

Criteria

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.

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

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
SuspendedOne Study Center