COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01005849
Recruitment Status : Terminated (because of low rate recruitment and the inability to reach the target expected)
First Posted : November 1, 2009
Last Update Posted : January 19, 2012
Sprim Advanced Life Sciences
Information provided by:
Lallemand SAS

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : October 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

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

Primary Outcome Measures :
  1. Occurence of traveler's diarrhea [ Time Frame: 3 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01005849

Layout table for location information
University of Milan
Milan, Italy
Sponsors and Collaborators
Lallemand SAS
Sprim Advanced Life Sciences
Layout table for investigator information
Principal Investigator: Mirella Pontello, Prof. University of Milan, Milan, Italy
Layout table for additonal information
Responsible Party: Dr. Henri Durand, Scientific Director, Lallemand SAS Identifier: NCT01005849    
Other Study ID Numbers: #09-prot-2-lal-01
First Posted: November 1, 2009    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: March 2011
Keywords provided by Lallemand SAS:
Traveler's diarrhea
Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases