Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02498418
Eligibility Criteria:
Inclusion Criteria:
1. Adult male or nonpregnant female aged ≥18 years non-indigenous travelers (for example; visiting students/faculty or international tourists) affected by naturally acquired acute diarrhea. Diarrhea is defined as the passage of at least 3 unformed stools in a 24-hour period. Stools are classified as formed (retains shape), soft (assumes shape of container), or watery (can be poured). When using this classification, both soft and watery stools are unformed and abnormal.
2. At least 3 unformed stools recorded within the 24 hours immediately preceding randomization.
3. At least 1 of the following signs and symptoms of enteric infection:
* abdominal pain or cramps
* nausea
* vomiting
* fecal urgency
* excessive gas/flatulence
* tenesmus
4. Women of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study.
Exclusion Criteria:
1. Pregnant, breast feeding, or planning a pregnancy.
2. Immediately prior to randomization, acute diarrhea for \>72 hours.
3. Presence of:
* fever (≥100 degrees fahrenheit \[°F\] or ≥37.8 degrees celsius \[°C\]), or
* hematochezia (blood in stool), or
* clinical findings suggesting moderate or severe dehydration.
4. Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, gastrointestinal (GI) tract (other than infectious diarrhea in travelers), or central nervous system.
5. Administration of any of the following:
* any antimicrobial agents with an expected activity against enteric bacterial pathogens within 7 days preceding randomization
* more than 2 doses of a symptomatic antidiarrheal compound such as antimotility agents, absorbent agents, and antisecretory agents within 8 hours preceding randomization
6. Use of any drug such as aspirin or ibuprofen (Advil), which can cause GI bleeding. Acetaminophen (Tylenol) or paracetamol is acceptable.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02498418
Study Brief:
Protocol Section:
NCT02498418