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 range
18 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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