Back to results

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

Primary Purpose

Traveler's Diarrhea

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

CBS 2004 (galacto-oligosaccharides)

Placebo

About this trial

This is an interventional prevention trial for Traveler's Diarrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

galacto-oligosaccharides

Placebo

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Assess the number of work days lost due to diarrhea

Assess percentages of subjects requiring treatment for diarrhea

Assess total number of diarrheal days

Full Information

NCT ID

NCT02736539

First Posted

April 5, 2016

Last Updated

July 18, 2017

Sponsor

Clasado Biosciences Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02736539

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Commercial strategy

Study Start Date

April 15, 2017 (Anticipated)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

February 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clasado Biosciences Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traveler's Diarrhea

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Description

galacto-oligosaccharides

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

CBS 2004 (galacto-oligosaccharides)

Intervention Description

CBS 2004 active treatment

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo treatment

Primary Outcome Measure Information:

Title

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.

Time Frame

7 weeks

Title

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

Time Frame

7 weeks

Secondary Outcome Measure Information:

Title

Assess the number of work days lost due to diarrhea

Time Frame

7 weeks

Title

Assess percentages of subjects requiring treatment for diarrhea

Time Frame

7 weeks

Title

Assess total number of diarrheal days

Time Frame

7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs