Status:
COMPLETED
Dose-finding Study of WS6788A, DS37-4 and H10407 Enterotoxigenic Escherichia Coli (ETEC) Challenge Strains
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Naval Medical Research Center
Conditions:
Diarrhea
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Five subjects will be admitted to the General Clinical Research Center (GCRC). The next day they will eat a light breakfast, fast for 90 minutes, ingest ETEC strain H10407, and fast for 90 more minute...
Detailed Description
The rationale for validation H10407 in the challenge study proposed at Johns Hopkins University is that this initial challenge study will support additional challenge studies planned for the future. I...
Eligibility Criteria
Inclusion
- Healthy adults age 18 to 45 years old who are willing to participate, complete training on ETEC and diarrhea and procedures of the protocol, pass the test documenting knowledge of the study, and give informed consent.
Exclusion
- age\<18 or \>45 years
- Chronic illness, chemical dependency, or significant medical illness as determined by the investigator.
- immunosuppressive condition or IgA (Immunoglobulin A) deficiency
- HIV antibody positive
- hepatitis B surface antigen positive
- hepatitis C antibody positive
- travel to ETEC endemic area within 2 years
- vaccination or other exposure to ETEC, cholera, or heat labile toxin (LT) toxin within 3 years
- pregnancy as defined by + serum or urine - human chorionic gonadotropin (HCG) on the day before immunization
- inability to pass the written examination
- use of antibiotic, H2 blocking agent or proton pump inhibitor within 7 days of challenge
- regular use of laxatives antacids or other agents to lower stomach acidity
- significant abnormality in screening lav hematology and chemistry tests as determined by the investigator.
- significant abnormality on EKG for those 40 to 50 years old as determined by the investigator.
- allergy to quinolones, penicillin's and Bactrim.
- abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day).
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00198796
Start Date
September 1 2005
End Date
May 30 2007
Last Update
April 11 2017
Active Locations (1)
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1
General Clinical Research Center
Baltimore, Maryland, United States, 21205