Finding studies
Finding studies
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Lead
Johns Hopkins Bloomberg School of Public Health
With
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-CFA/I 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.
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
