Probiotics and the Prevention of Traveler's Diarrhea (TD)

A Parallel, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Probiotic Formula in 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.

Study Overview

• Status: Terminated
• Conditions: Travelers' Diarrhea
• Intervention / Treatment: Dietary supplement: Protecflor; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • University of Milan

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. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; 1 Capsule to be taken once a day during the entire study period
Experimental: Protecflor	Dietary supplement: Protecflor; 1 Capsule to be taken once a day during the entire study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurence of traveler's diarrhea	3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number and consistency of stools (normal, soft or unformed)	3 weeks
Duration of traveler's diarrhea if occurred (# days)	3 weeks
Presence of symptoms associated with TD (cramps, nausea, fever, blood in the stools, vomiting, bloating, flatulence, visceral pain)	3 weeks
Need for rescue medication	3 weeks

Collaborators and Investigators

• Sponsor: Lallemand SAS
• Collaborators: Sprim Advanced Life Sciences
• Investigators: Principal Investigator: Mirella Pontello, Prof., University of Milan, Milan, Italy

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: October 30, 2009
• First Submitted That Met QC Criteria: October 30, 2009
• First Posted (Estimate): November 1, 2009

Study Record Updates

• Last Update Posted (Estimate): January 19, 2012
• Last Update Submitted That Met QC Criteria: January 18, 2012
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Probiotics; Prevention; Traveler's diarrhea
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Diarrhea; Dysentery
• Other Study ID Numbers: #09-prot-2-lal-01