Clinical Trial of CBS-2004 in Prevention of Travelers' Diarrhea

Clasado

Status and phase: Withdrawn; Phase 3

Conditions: Traveler's Diarrhea

Treatments: Drug: Placebo; Drug: CBS 2004 (galacto-oligosaccharides)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02736539

IDCRP-080

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy subjects, 18 years old or older
2. Travel on moderate-high risk itinerary for traveler's diarrhea for minimum of 14 days and maximum of 6 weeks travel
3. Able to comply with study and follow-up procedures
4. Subjects willing and able to enter data in the diary card
5. An IRB approved informed consent form is signed and dated
6. Subjects must have adequate general health (as determined by investigators)
7. 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

1. Allergy to investigational product
2. History of functional bowel disorder (including IBS)
3. 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
4. Antibiotic use within 7 days prior to enrollment (except for malaria prophylaxis excluding doxycycline)
5. 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.
6. Lactose intolerant (allergies to dairy products).
7. Medications usage as deemed by the PI to interfere with GI function
8. Diarrheal illness within 7 days prior to enrollment
9. Subject has a concomitant disease or condition that could interfere with or for which treatment could interfere with the conduct of the study, or could in the opinion of the investigator increase the risk of adverse events (AEs) during the subject's participation in the study.
10. Use of any investigational or non-registered drug other than the study drug within 30 days preceding the study enrollment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

galacto-oligosaccharides

Treatment:

Drug: CBS 2004 (galacto-oligosaccharides)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo