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

NCT ID: NCT02736539

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-15
• Study Completion Date: 2019-02-28

Brief 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.

Conditions

Traveler's Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Active

galacto-oligosaccharides

Group Type: EXPERIMENTAL

CBS 2004 (galacto-oligosaccharides)

Intervention Type: DRUG

CBS 2004 active treatment

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo treatment

Interventions

CBS 2004 (galacto-oligosaccharides)

CBS 2004 active treatment

Intervention Type: DRUG

Placebo

Placebo treatment

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clasado Biosciences Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IDCRP-080

Identifier Type: -

Identifier Source: org_study_id