Probiotics and the Prevention of Traveler's Diarrhea

Travelers' Diarrhea Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01005849
• Other study ID #: #09-prot-2-lal-01
• Status: Terminated
• Phase: Phase 4
• First received: October 30, 2009
• Last updated: January 18, 2012
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: March 2011
• Source: Lallemand SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 420
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Dysentery
• Travelers' Diarrhea

Intervention

Dietary Supplement:
• Protecflor
1 Capsule to be taken once a day during the entire study period
• Placebo
1 Capsule to be taken once a day during the entire study period

Locations

Country	Name	City	State
Italy	University of Milan	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Lallemand SAS	Sprim Advanced Life Sciences

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of traveler's diarrhea		3 weeks	No
Secondary	Number and consistency of stools (normal, soft or unformed)		3 weeks	No
Secondary	Duration of traveler's diarrhea if occurred (# days)		3 weeks	No
Secondary	Presence of symptoms associated with TD (cramps, nausea, fever, blood in the stools, vomiting, bloating, flatulence, visceral pain)		3 weeks	Yes
Secondary	Need for rescue medication		3 weeks	No