Phase
Condition
Lactose Intolerance
Stomach Discomfort
Colic
Treatment
Loperamide
Azithromycin 500 MG
Rifaximin 550 MG
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Active duty military, 18-60 years old
Presence of acute watery diarrhea (3 or more loose/liquid stools in 24 hours or 2loose/liquid stools in 24 hours and associated symptoms such as nausea, vomiting,abdominal cramps or tenesmus) lasting <96 hours in duration that impacts function inactivities and/or performance of primary duties. Refer to recruitment decision treebelow.
Eligible for ambulatory management. (Note: Ambulatory management in this study meansthat the patient can be treated on an outpatient basis to include up to 23 hours ofmedical observation and IV therapies.)
Able to comply with follow-up procedures.
Will remain in country for at least 7 days or an assurance that follow-up can bearranged elsewhere.
Exclusion
Exclusion Criteria:
Allergy to rifamycins, macrolides, or loperamide (not including mildgastrointestinal upset).
Antibiotic therapy in the 72 hours prior to presentation (excluding malariaprophylaxis with mefloquine, malarone, chloroquine/proguanil, tafenoquine, ordoxycycline).
Concomitant medications with known drug-drug interactions with any of the studydrugs (includes theophylline, digoxin, warfarin, chloroquine andhydroxychloroquine).
Current or history of liver disease or other serious health conditions based onreview by study physician.
Acute dysentery and/or febrile illness (temperature > 100.4°F [38.1°C]).
Presence of symptoms >96 hours prior to initiating treatment.
Use of >4 mg loperamide or use of any amount of loperamide for greater than 24 hoursprior to enrollment. Prior use of bismuth subsalicylate or other anti-diarrheal,non-antibiotic therapy in the 48 hours prior to enrollment.
Positive pregnancy test at presentation (unknown effects with rifaximin). All femaleparticipants will be administered a urine pregnancy test prior to enrollment.
Previously screened or randomized in this study.
Study Design
Connect with a study center
Camp Lemonnier Djibouti
Djibouti,
DjiboutiActive - Recruiting
JTF-Bravo, Soto Cano AB
Comayagua,
HondurasActive - Recruiting
British Army Training Site UK
Nanyuki,
KenyaSite Not Available
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