Parasitic Infections of the Gastrointestinal Tract

NCT00001162 | Terminated

• 2 other identifiers: 77009477-I-0094
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Amebiasis; Cryptosporidiosis; Giardiasis; Parasitic Disease; Parasitic Intestinal Disease; Gastrointestinal Helminth Infections

Keywords

Giardia; Helminth; Cryptosporidium; Hookworms; Trichuris; Strongyloides; Protozoa; Small Bowel Biopsy; E. Histolytica; Duodenal Aspiration; Coccidiosis; Clonorchis; Amebiasis; Parasitic Disease; Tapeworm; Trichinosis; Gastrointestinal Trematodes; Opisthorchis; Paragonimiasis; Echinococcus

Outcome Measures

Primary Outcomes (2)

• To Collect and study different parasite populations to study and/or axenization of specific parasites, analyze immune responses to homologous or heterologous parasites, and the development of diagnostic tests

  Screening visit

• Off label use of FDA approved drugs for treatment of Giardiasis in patients who cannot be cured otherwise, determining empirically which regimen is effective and safe

  Post Tx follow up visit

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subject unwilling or unable to comply with requirements of the protocol in the opinion of the investigator.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Kulakova L, Singer SM, Conrad J, Nash TE. Epigenetic mechanisms are involved in the control of Giardia lamblia antigenic variation. Mol Microbiol. 2006 Sep;61(6):1533-42. doi: 10.1111/j.1365-2958.2006.05345.x.

  PMID: 16968226 BACKGROUND

• Ungar BL, Yolken RH, Nash TE, Quinn TC. Enzyme-linked immunosorbent assay for the detection of Giardia lamblia in fecal specimens. J Infect Dis. 1984 Jan;149(1):90-7. doi: 10.1093/infdis/149.1.90.

  PMID: 6363569 BACKGROUND

• Nutman TB, Hussain R, Ottesen EA. IgE production in vitro by peripheral blood mononuclear cells of patients with parasitic helminth infections. Clin Exp Immunol. 1984 Oct;58(1):174-82.

  PMID: 6478649 BACKGROUND

MeSH Terms

Conditions

Amebiasis; Cryptosporidiosis; Giardiasis; Parasitic Diseases; Intestinal Diseases, Parasitic; Hookworm Infections; Coccidiosis; Cestode Infections; Trichinellosis; Paragonimiasis; Echinococcosis

Condition Hierarchy (Ancestors)

Protozoan Infections; Infections; Protozoan Infections, Animal; Parasitic Diseases, Animal; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Animal Diseases; Strongylida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Enoplida Infections; Adenophorea Infections; Trematode Infections

Study Officials

• Theodore E Nash, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: May 23, 1977
• Study Completion: May 31, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-05-31

Locations

US (1)