Back to resultsProbiotics and the Prevention of Traveler's Diarrhea (TD)
Primary Purpose
Travelers' Diarrhea
Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Protecflor
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Travelers' Diarrhea focused on measuring Probiotics, Traveler's diarrhea, Prevention
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects aged 18 or over. Upper age limit set by subject's ability to participate in the study;
- Subject must give written informed consent;
- Plan to travel to a geographic area with high risk of TD with a travel duration between 12 and 14 days;
- Subjects must be willing to refrain from using anti-diarrheal medications or antibiotics during the study period, unless they become clinically indicated in which case a rescue regimen can be administered;
- Subjects willing to refrain from eating yoghurt and taking other probiotics during the study;
- Female subjects of child-bearing potential must agree to use adequate birth control during the study period. This will be defined as hormonal contraception or a double barrier-method.
Exclusion Criteria:
- Subjects who have been previously treated with PROTECFLOR® or who have participated in previous Lallemand-sponsored studies;
- Subjects who have been born in a developing country.
- Subjects with a history of substance or alcohol abuse or any other psychological condition that may, in the investigator's opinion, adversely affect their co-operation with the study;
- Subjects who receive a cholera vaccine
- Subjects with chronic diarrhea;
- Subjects with chronic disease such as irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD) or ulcerative colitis (UC) ;
- Subjects with gastrointestinal (GI) surgery during the last 3 months;
- Subjects who took systemic antibiotic 15 days or less prior to the study;
- Subjects with immunodeficiency's or immune suppression;
- Subjects being treated for cancer with radiotherapy and/or chemotherapy;
- Subjects with organ transplants;
- Subjects treated with immunosuppressant drugs;
- Subjects receiving another probiotic preparations or having received probiotic preparations within the last 15 days;
- Subjects with tube feeding, ileostomy and colostomy;
- Subjects diagnosed Clostridium difficile colitis within the last 3 months;
- Women who are pregnant, or who will not consent to using adequate birth control during the study period;
- Women who are breastfeeding.
Sites / Locations
- University of Milan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Protecflor
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Occurence of traveler's diarrhea
Secondary Outcome Measures
Number and consistency of stools (normal, soft or unformed)
Duration of traveler's diarrhea if occurred (# days)
Presence of symptoms associated with TD (cramps, nausea, fever, blood in the stools, vomiting, bloating, flatulence, visceral pain)
Need for rescue medication
Full Information
NCT ID
NCT01005849
First Posted
October 30, 2009
Last Updated
January 18, 2012
Sponsor
Lallemand SAS
Collaborators
Sprim Advanced Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01005849
Brief Title
Probiotics and the Prevention of Traveler's Diarrhea
Acronym
TD
Official Title
A Parallel, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Probiotic Formula in the Prevention of Traveler's Diarrhea
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
because of low rate recruitment and the inability to reach the target expected
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lallemand SAS
Collaborators
Sprim Advanced Life Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present study is designed to evaluate the effect of a mixture of probiotics on the prevention of traveler's diarrhea (TD) in subjects who travel to a country with a high risk for developing TD. Subjects will be asked to take one capsule containing a mixture of probiotics or a placebo capsule a day, within the week before departure, during the travel and up to 3 days after return. They will note the following outcomes in a diary: occurence of diarrhea, number and consistency of stools, duration of the diarrhea, presence of diarrhea-related symptoms and need for rescue medication.
The present study will examine if the use of the probiotics capsule reduces the occurence of traveler's diarrhea as compared to the placebo capsule.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Travelers' Diarrhea
Keywords
Probiotics, Traveler's diarrhea, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protecflor
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Protecflor
Intervention Description
1 Capsule to be taken once a day during the entire study period
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
1 Capsule to be taken once a day during the entire study period
Primary Outcome Measure Information:
Title
Occurence of traveler's diarrhea
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Number and consistency of stools (normal, soft or unformed)
Time Frame
3 weeks
Title
Duration of traveler's diarrhea if occurred (# days)
Time Frame
3 weeks
Title
Presence of symptoms associated with TD (cramps, nausea, fever, blood in the stools, vomiting, bloating, flatulence, visceral pain)
Time Frame
3 weeks
Title
Need for rescue medication
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female subjects aged 18 or over. Upper age limit set by subject's ability to participate in the study;
Subject must give written informed consent;
Plan to travel to a geographic area with high risk of TD with a travel duration between 12 and 14 days;
Subjects must be willing to refrain from using anti-diarrheal medications or antibiotics during the study period, unless they become clinically indicated in which case a rescue regimen can be administered;
Subjects willing to refrain from eating yoghurt and taking other probiotics during the study;
Female subjects of child-bearing potential must agree to use adequate birth control during the study period. This will be defined as hormonal contraception or a double barrier-method.
Exclusion Criteria:
Subjects who have been previously treated with PROTECFLOR® or who have participated in previous Lallemand-sponsored studies;
Subjects who have been born in a developing country.
Subjects with a history of substance or alcohol abuse or any other psychological condition that may, in the investigator's opinion, adversely affect their co-operation with the study;
Subjects who receive a cholera vaccine
Subjects with chronic diarrhea;
Subjects with chronic disease such as irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD) or ulcerative colitis (UC) ;
Subjects with gastrointestinal (GI) surgery during the last 3 months;
Subjects who took systemic antibiotic 15 days or less prior to the study;
Subjects with immunodeficiency's or immune suppression;
Subjects being treated for cancer with radiotherapy and/or chemotherapy;
Subjects with organ transplants;
Subjects treated with immunosuppressant drugs;
Subjects receiving another probiotic preparations or having received probiotic preparations within the last 15 days;
Subjects with tube feeding, ileostomy and colostomy;
Subjects diagnosed Clostridium difficile colitis within the last 3 months;
Women who are pregnant, or who will not consent to using adequate birth control during the study period;
Women who are breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirella Pontello, Prof.
Organizational Affiliation
University of Milan, Milan, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Milan
City
Milan
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Probiotics and the Prevention of Traveler's Diarrhea
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