Efficacy of Anti-CFA/I and CfaE Bovine Milk Immunoglobulin Against Challenge With H10407 ETEC Expressing CFA/I (BIgGI)
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|ClinicalTrials.gov Identifier: NCT00435526|
Recruitment Status : Completed
First Posted : February 15, 2007
Last Update Posted : February 15, 2007
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea||Biological: anti-CFA/I bovine IgG, and anti-CfaE bovine IgG||Phase 1|
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
- 10 BIgG anti-CFA/I
- 10 BIgG anti-CfaE
- 10 LactoFree® Lipil®
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||March 2006|
|Study Completion Date :||October 2006|
- Clinical diagnosis of diarrhea defined as 1 loose/liquid stool (≥ Grade 3) of >300 g OR ≥ 2 loose/liquid stools totaling ≥ 200 g during any 48-hour period within 120 hours of challenge with ETEC strain H10407.
- Prevention of moderate to severe diarrhea.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435526
|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|