TD: Probiotics and the Prevention of Traveler's Diarrhea

• Sponsor: Lallemand SAS (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01005849
• Collaborator: Sprim Advanced Life Sciences (Other)
• Enrollment: 420
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 18.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Travelers' Diarrhea	Dietary Supplement: Protecflor; Dietary Supplement: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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 Start Date: Oct 1, 2009
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Occurence of traveler's diarrhea [3 weeks]

Secondary Outcome Measures

1. Number and consistency of stools (normal, soft or unformed) [3 weeks]

2. Duration of traveler's diarrhea if occurred (# days) [3 weeks]

3. Presence of symptoms associated with TD (cramps, nausea, fever, blood in the stools, vomiting, bloating, flatulence, visceral pain) [3 weeks]

4. Need for rescue medication [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Milan	Milan		Italy

Sponsors and Collaborators

• Lallemand SAS
• Sprim Advanced Life Sciences

Investigators

• Principal Investigator: Mirella Pontello, Prof., University of Milan, Milan, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01005849
• Other Study ID Numbers: #09-prot-2-lal-01
• First Posted: Nov 1, 2009
• Last Update Posted: Jan 19, 2012
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: Probiotics; Traveler's diarrhea; Prevention
• Additional relevant MeSH terms: Dysentery; Diarrhea

Study Results

No Results Posted as of Jan 19, 2012