NCT01005849

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 19, 2012

Status Verified

March 1, 2011

Enrollment Period

1.9 years

First QC Date

October 30, 2009

Last Update Submit

January 18, 2012

Conditions

Travelers' Diarrhea

Keywords

ProbioticsTraveler's diarrheaPrevention

Outcome Measures

Primary Outcomes (1)

  • Occurence of traveler's diarrhea

    3 weeks

Secondary Outcomes (4)

  • Number and consistency of stools (normal, soft or unformed)

    3 weeks

  • Duration of traveler's diarrhea if occurred (# days)

    3 weeks

  • Presence of symptoms associated with TD (cramps, nausea, fever, blood in the stools, vomiting, bloating, flatulence, visceral pain)

    3 weeks

  • Need for rescue medication

    3 weeks

Study Arms (2)

Protecflor

EXPERIMENTAL
Dietary Supplement: Protecflor

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

ProtecflorDIETARY_SUPPLEMENT

1 Capsule to be taken once a day during the entire study period

Protecflor
PlaceboDIETARY_SUPPLEMENT

1 Capsule to be taken once a day during the entire study period

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Milan

Milan, Italy

Location

Study Officials

  • Mirella Pontello, Prof.

    University of Milan, Milan, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 19, 2012

Record last verified: 2011-03

Locations

IT(1)