Clinical Trial of CBS-2004 in Prevention of Travelers' Diarrhea (NCT02736539) | Clinical Trial Compass
WithdrawnPhase 3
Clinical Trial of CBS-2004 in Prevention of Travelers' Diarrhea
Stopped: Commercial strategy
0Started 2017-04-15
Plain-language summary
This study is designed as a randomized double-blinded treatment trial among travelers' to geographical areas with moderate-severe rates of traveler's diarrhea. Travelers will be randomized to receive CBS 2004 or masked placebo to be taken daily while traveling. The test article or placebo will be taken starting 7 days prior to travel.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy subjects, 18 years old or older
✓. Travel on moderate-high risk itinerary for traveler's diarrhea for minimum of 14 days and maximum of 6 weeks travel
✓. Able to comply with study and follow-up procedures
✓. Subjects willing and able to enter data in the diary card
✓. An IRB approved informed consent form is signed and dated
✓. Subjects must have adequate general health (as determined by investigators)
✓. Women: Non-nursing and negative urine/serum pregnancy test with understanding through informed consent process to avoid pregnancy during the study while on the study drug. Should an individual have a documented surgical sterilization in her medical record, a pregnancy test will not be required. If a volunteer becomes pregnant during the study, the Principal Investigator (PI) will notify the study research monitor and the Institutional Review Boards (IRBs). The pregnancy outcome will be followed per IRB and other regulatory requirements.
Exclusion criteria
✕. Allergy to investigational product
✕. History of functional bowel disorder (including IBS)
✕. Chronic intestinal disease (ulcerative colitis, crohn's disease), post vagotomy diabetic autonomic neuropathy, malabsorption, short bowel syndrome, celiac disease, bacterial overgrowth due to blind loops, pancreatitis
✕
What they're measuring
1
Assess safety and tolerance by evaluating the adverse events reported with study drug and placebo during the period of prophylaxis and through the last clinic visit.
Timeframe: 7 weeks
2
To assess the effectiveness of CBS 2004 by evaluating the development of traveler's diarrhea (TD) with CBS-2004 versus placebo based on time to first unformed stool associated with a TD episode
. Antibiotic use within 7 days prior to enrollment (except for malaria prophylaxis excluding doxycycline)
✕. Use of other probiotics or prebiotics (outside of the study product) in the prior 3-weeks or intent to use during the study period. This includes the over-the-counter preparations of probiotics, prebiotics (including inulin, lactulose) or consumption of a bio-yogurt product.
✕. Lactose intolerant (allergies to dairy products).
✕. Medications usage as deemed by the PI to interfere with GI function
✕. Diarrheal illness within 7 days prior to enrollment