Dose-finding Study of WS6788A, DS37-4 and H10407 Enterotoxigenic Escherichia Coli (ETEC) Challenge Strains

Completed · Phase 1

Conditions studied: Diarrhea

In brief

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 minutes. After this challenge they will be monitored closely , and all stools will be collected, graded and weighed. On Day 5, or sooner if indicated, they will begin antibiotics to eradicate the challenge strain. They will be scheduled for discharge on Day 7 but may leave a few days earlier if early antibiotic treatment is given. Hypothesis: A challenge dose of 10(9) colony forming unit (CFU) of ETEC strain H10407, will cause diarrhea in at least 60% of subjects.

Key facts

Study ID

NCT00198796

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

5

Starts

2005-09-01

Expected to finish

2007-05-30

Last updated by the study team

2017-04-11

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• General Clinical Research Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.