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

This study has been terminated.
(because of low rate recruitment and the inability to reach the target expected)
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by:
Lallemand SAS
ClinicalTrials.gov Identifier:
NCT01005849
First received: October 30, 2009
Last updated: January 18, 2012
Last verified: March 2011
  Purpose

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 Intervention Phase
Travelers' Diarrhea
Dietary Supplement: Protecflor
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Lallemand SAS:

Primary Outcome Measures:
  • Occurence of traveler's diarrhea [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and consistency of stools (normal, soft or unformed) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Duration of traveler's diarrhea if occurred (# days) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Presence of symptoms associated with TD (cramps, nausea, fever, blood in the stools, vomiting, bloating, flatulence, visceral pain) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Need for rescue medication [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 420
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005849

Locations
Italy
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
  More Information

No publications provided

Responsible Party: Dr. Henri Durand, Scientific Director, Lallemand SAS
ClinicalTrials.gov Identifier: NCT01005849     History of Changes
Other Study ID Numbers: #09-prot-2-lal-01
Study First Received: October 30, 2009
Last Updated: January 18, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Lallemand SAS:
Probiotics
Traveler's diarrhea
Prevention

Additional relevant MeSH terms:
Diarrhea
Dysentery
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 16, 2014