Clinical trial NCT01005849: Probiotics and the Prevention of Traveler's Diarrhea
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Travelers' Diarrhea
Keywords: Probiotics
Traveler's diarrhea
Prevention
Lead sponsor: Lallemand SAS
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2009-11-01
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurence of traveler's diarrhea
timeFrame: 3 weeks
Secondary outcomes:
measure: Number and consistency of stools (normal, soft or unformed)
timeFrame: 3 weeks
measure: Duration of traveler's diarrhea if occurred (# days)
timeFrame: 3 weeks
measure: Presence of symptoms associated with TD (cramps, nausea, fever, blood in the stools, vomiting, bloating, flatulence, visceral pain)
timeFrame: 3 weeks
measure: Need for rescue medication
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: University of Milan
Study officials:
affiliation: University of Milan, Milan, Italy
name: Mirella Pontello, Prof.
role: PRINCIPAL_INVESTIGATOR
References: