Probiotics and the Prevention of Traveler's Diarrhea
Probiotics and the Prevention of Traveler's Diarrhea
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.
Inclusion Criteria:

 1. Male and female subjects aged 18 or over. Upper age limit set by subject's ability to
 participate in the study;

 2. Subject must give written informed consent;

 3. Plan to travel to a geographic area with high risk of TD with a travel duration
 between 12 and 14 days;

 4. 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;

 5. Subjects willing to refrain from eating yoghurt and taking other probiotics during the
 study;

 6. 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:

 1. Subjects who have been previously treated with PROTECFLOR® or who have participated in
 previous Lallemand-sponsored studies;

 2. Subjects who have been born in a developing country.

 3. 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;

 4. Subjects who receive a cholera vaccine

 5. Subjects with chronic diarrhea;

 6. Subjects with chronic disease such as irritable bowel syndrome (IBS) or inflammatory
 bowel disease (IBD) or ulcerative colitis (UC) ;

 7. Subjects with gastrointestinal (GI) surgery during the last 3 months;

 8. Subjects who took systemic antibiotic 15 days or less prior to the study;

 9. Subjects with immunodeficiency's or immune suppression;

 10. Subjects being treated for cancer with radiotherapy and/or chemotherapy;

 11. Subjects with organ transplants;

 12. Subjects treated with immunosuppressant drugs;

 13. Subjects receiving another probiotic preparations or having received probiotic
 preparations within the last 15 days;

 14. Subjects with tube feeding, ileostomy and colostomy;

 15. Subjects diagnosed Clostridium difficile colitis within the last 3 months;

 16. Women who are pregnant, or who will not consent to using adequate birth control during
 the study period;

 17. Women who are breastfeeding.