None listed
Conditions
Interventions
Randomized patients
will self-administer 3 tablets a day for 3 days, (1 tablet every 8 hours), for a total dose of
9 tablets. Day 1 of the study will be considered to begin when the patient take
Sponsors
Alvogen Pine Brook, LLC,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Patient is able to read and understand the language of the informed consent and Patient eDiary 2. Patient has signed an informed consent form 3. Adult male or non-pregnant female aged ≥ 18 years 4. International travelers (e.g. visiting students / faculty or international tourists) who arrived from their country of residence within 30 days of the Screening and Randomization visit 5. Affected by naturally acquired acute diarrhea, defined as the passage of at least three unformed stools within the 24 hours immediately preceding randomization (see Section 11.2.1 for definition of unformed and formed stools) 6. At least one of the following signs and symptoms of enteric infection within the 24 hours immediately preceding randomization: • Abdominal pain or cramps • Nausea • Vomiting • Fecal urgency • Excessive gas/flatulence • Tenesmus
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study medication 2. Presence of a medical condition with regular GI symptoms, e.g. Crohn’s disease, ulcerative colitis, indeterminate colitis, previous bowel surgery which impacts absorption long term, thyrotoxicosis, short bowel syndrome 3. Patient requires medication which alters GI function 4. Patient requires use of long term antibiotics (e.g. urinary tract infection prophylaxis, acne) 5. Pregnant, breast feeding, or planning a pregnancy 6. Immediately prior to randomization, acute diarrhea for > 72 hours 7. Presence of: • Fever (≥ 100 °F or ≥ 37.8 °C), or • Hematochezia (blood in stool), or • Clinical findings suggesting moderate or severe dehydration
Countries
Brazil, Mexico, Peru, Puerto Rico
Contacts
Public ContactMaria Cristina Eyzaguirre
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed