Probiotics and the Prevention of Traveler's Diarrhea - Full Text View

Sponsor:	Lallemand SAS
Collaborator:	Sprim Italy
Information provided by:	Lallemand SAS
ClinicalTrials.gov Identifier:	NCT01005849

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Bowel Movement Diarrhea Dietary Supplements Diets Giardia Infections Nausea and Vomiting

U.S. FDA Resources

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 ]

Estimated Enrollment:	420
Study Start Date:	October 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Protecflor: Experimental	Dietary Supplement: Protecflor 1 Capsule to be taken once a day during the entire study period
Placebo: Placebo Comparator	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:

Male and female subjects aged 18 or over. Upper age limit set by subject's ability to participate in the study;
Subject must give written informed consent;
Plan to travel to a geographic area with high risk of TD with a travel duration between 12 and 14 days;
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;
Subjects willing to refrain from eating yoghurt and taking other probiotics during the study;
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:

Subjects who have been previously treated with PROTECFLOR® or who have participated in previous Lallemand-sponsored studies;
Subjects who have been born in a developing country.
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;
Subjects who receive a cholera vaccine
Subjects with chronic diarrhea;
Subjects with chronic disease such as irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD) or ulcerative colitis (UC) ;
Subjects with gastrointestinal (GI) surgery during the last 3 months;
Subjects who took systemic antibiotic 15 days or less prior to the study;
Subjects with immunodeficiency's or immune suppression;
Subjects being treated for cancer with radiotherapy and/or chemotherapy;
Subjects with organ transplants;
Subjects treated with immunosuppressant drugs;
Subjects receiving another probiotic preparations or having received probiotic preparations within the last 15 days;
Subjects with tube feeding, ileostomy and colostomy;
Subjects diagnosed Clostridium difficile colitis within the last 3 months;
Women who are pregnant, or who will not consent to using adequate birth control during the study period;
Women who are breastfeeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005849

Contacts

Contact: Arienne de Jong, PhD	+390245495838	arienne.dejong@sprim.com
Contact: Elena De Gregorio, MSc	+390245495838	elena.degregorio@sprim.com

Locations

Italy
University of Milan
Milan, Italy

Sponsors and Collaborators

Lallemand SAS

Sprim Italy

Investigators

Principal Investigator:

Mirella Pontello, Prof.

University of Milan, Milan, Italy

More Information

No publications provided

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

Keywords provided by Lallemand SAS:

Probiotics
Traveler's diarrhea
Prevention

Additional relevant MeSH terms:

Protozoan Infections
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Mastigophora Infections
Giardiasis
Intestinal Diseases

Signs and Symptoms
Digestive System Diseases
Dysentery
Parasitic Diseases
Sarcomastigophora Infections
Intestinal Diseases, Parasitic
Gastroenteritis

ClinicalTrials.gov processed this record on February 08, 2010