This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C. jejuni.
30 healthy volunteers (2 of these were planned alternates) gave informed consent and were enrolled to participate in a study to determine the efficacy of prophylactic rifaximin in preventing diarrheal illness following challenge with C. jejuni, strain CG8421. Volunteers were screened for inclusion and exclusion criteria and were admitted to the inpatient unit of the Center for Immunization Research at Johns Hopkins University. Volunteers were treated with rifaximin or placebo in a double blind manner for four days, beginning the day prior to challenge. On the day of challenge, the volunteers were given 5x10(5) C. jejuni with bicarbonate buffer and were then monitored and treated for any symptoms. Stools were cultured daily for the excretion of C. jejuni and all subjects were treated with antibiotics to insure that the challenge strain has cleared prior to to discharge. Subjects were followed for six months following the inpatient phase to detect adverse events following the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
30
Rifaximin administered then Challenge with C jejuni
Placebo administered then Challenge with C jejuni
Center for Immunization Research, Johns Hopkins Bloomberg School of Public Heatlh
Baltimore, Maryland, United States
Campylobacteriosis
A clinical illness meeting at least one of the following patterns: * Moderate to severe diarrhea. * Fever (present on at least 2 occasions, at least 20 minutes apart) without diarrhea, plus an associated symptom (nausea, vomiting, abdominal cramps, tenesmus, or gross blood in ≥ 2 stools); with consideration of potential alternative diagnosis per clinical investigator based on illness time course and associated symptoms.
Time frame: 120 hours after challenge
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