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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02736539
Recruitment Status : Withdrawn (Commercial strategy)
First Posted : April 13, 2016
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Clasado Biosciences Ltd

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.

Condition or disease Intervention/treatment Phase
Traveler's Diarrhea Drug: CBS 2004 (galacto-oligosaccharides) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Trial of CBS-2004 in Prevention of Travelers' Diarrhea
Estimated Study Start Date : April 15, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Active
galacto-oligosaccharides
Drug: CBS 2004 (galacto-oligosaccharides)
CBS 2004 active treatment

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo treatment




Primary Outcome Measures :
  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. [ Time Frame: 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 [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. Assess the number of work days lost due to diarrhea [ Time Frame: 7 weeks ]
  2. Assess percentages of subjects requiring treatment for diarrhea [ Time Frame: 7 weeks ]
  3. Assess total number of diarrheal days [ Time Frame: 7 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: Clasado Biosciences Ltd
ClinicalTrials.gov Identifier: NCT02736539    
Other Study ID Numbers: IDCRP-080
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dysentery
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases