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

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.

Study Overview

• Status: Withdrawn
• Conditions: Traveler's Diarrhea
• Intervention / Treatment: Drug: CBS 2004 (galacto-oligosaccharides); Drug: Placebo

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo treatment
Experimental: Active; galacto-oligosaccharides	Drug: CBS 2004 (galacto-oligosaccharides); CBS 2004 active treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Clasado Biosciences Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Diarrhea; Dysentery
• Other Study ID Numbers: IDCRP-080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No