Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435526
Status:
COMPLETED
Last Update Posted:
2007-02-15
First Post:
2007-02-13
Brief Title:
Efficacy of Anti-CFAI and CfaE Bovine Milk Immunoglobulin Against Challenge With H10407 ETEC Expressing CFAI
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Protective Efficacy of Orally Delivered Bovine Milk Immunoglobulin BIgG Specific for the Minor CFAI Fimbrial Adhesin CfaE Against Challenge With H10407 Enterotoxigenic E Coli ETEC Strain Expressing CFAI
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIgGI
Brief Summary:
The purpose of this study is to assess anti-CFAI and anti-CfaE BIgG safety and to determine protective efficacy of anti-CFAI and anti-CfaE BIgG against diarrhea after challenge with H10407 a CFAI-expressing ETEC strain
Detailed Description:
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
1 10 BIgG anti-CFAI
2 10 BIgG anti-CfaE
3 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
Group N Product
1 10 BIgG anti-CFAI
2 10 BIgG anti-CfaE
3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HMJF Sub Award 0000090523 | None | None | None |