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

NCT02736539 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: IDCRP-080
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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.

  7 weeks

• 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

  7 weeks

Secondary Outcomes (3)

• Assess the number of work days lost due to diarrhea

  7 weeks

• Assess percentages of subjects requiring treatment for diarrhea

  7 weeks

• Assess total number of diarrheal days

  7 weeks

Study Arms (2)

Active

EXPERIMENTAL

galacto-oligosaccharides

Drug: CBS 2004 (galacto-oligosaccharides)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CBS 2004 (galacto-oligosaccharides) DRUG

CBS 2004 active treatment

Active

Placebo DRUG

Placebo treatment

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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.
• Use of any investigational or non-registered drug other than the study drug within 30 days preceding the study enrollment.

Sponsors & Collaborators

• Clasado Biosciences Ltd: lead

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 13, 2016
• Study Start: April 15, 2017
• Primary Completion: December 31, 2018
• Study Completion: February 28, 2019
• Last Updated: July 21, 2017

Record last verified: 2017-07