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Sponsors and Collaborators: |
Johns Hopkins Bloomberg School of Public Health Naval Medical Research Center Walter Reed Army Institute of Research (WRAIR) |
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Information provided by: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT00435526 |
The purpose of this study is to assess anti-CFA/I and anti-CfaE BIgG safety and to determine protective efficacy of anti-CFA/I and anti-CfaE BIgG against diarrhea after challenge with H10407, a CFA/I-expressing ETEC strain.
Condition | Intervention | Phase |
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Diarrhea |
Biological: anti-CFA/I bovine IgG, and anti-CfaE bovine IgG |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Protective Efficacy of Orally Delivered Bovine Milk Immunoglobulin (BIgG) Specific for the Minor CFA/I Fimbrial Adhesin CfaE Against Challenge With H10407 Enterotoxigenic E. Coli (ETEC) Strain Expressing CFA/I |
Estimated Enrollment: | 30 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | October 2006 |
This is a Randomized, double-blinded, placebo-controlled trial involving up to 33 subjects. Subjects will be randomized into one of the following three groups.
Group N Product
Volunteers will receive the test article three times daily following meals beginning 2 days prior to oral ETEC challenge (strain H10407). Test article will be administered for a total of 7 days. Monitoring procedures will assess volunteer safety, the primary endpoint (diarrhea), stool microbiology (H10407 excretion), and ETEC-specific immunology. All volunteers will receive antibiotic treatment (ciprofloxacin, trimethoprim-sulfamethoxazole or amoxicillin) starting 5 days after ETEC challenge or sooner based on pre-defined clinical criteria. Follow-up visits for 2 weeks post-discharge will monitor safety and immunological parameters.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins Bayview Medicial Center, Inpatient Unit | |
Baltimore, Maryland, United States, 21224 | |
General Clinical Research Center | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Robin McKenzie, M.D. | Johns Hopkins School of Public |
Study ID Numbers: | CIR 218, HMJF Sub Award # 0000090523 |
Study First Received: | February 13, 2007 |
Last Updated: | February 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00435526 |
Health Authority: | United States: Food and Drug Administration |
traveler's diarrhea ETEC diarrhea passive immunization bovine milk prophylaxis |
Signs and Symptoms Antibodies Diarrhea Signs and Symptoms, Digestive Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |