Travelers' DiarrheaPhase 4TDNCT01005849
Probiotics and the Prevention of Traveler's Diarrhea
A Phase 4 study testing Protecflor in people with Travelers' Diarrhea, run by Lallemand SAS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Travelers' Diarrhea
- What is being tested?
- Protecflor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2009to Sep 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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) ;
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Conditions
- Travelers' Diarrhea
- Being tested
- Protecflor, Placebo
- Keywords
- Probiotics, Traveler's diarrhea, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProtecflorDietary supplement
1 Capsule to be taken once a day during the entire study period
PlaceboDietary supplement
1 Capsule to be taken once a day during the entire study period
| Study group | Role | What they receive |
|---|---|---|
| Protecflor | Experimental | Not described Receives: Dietary Supplement: Protecflor |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of traveler's diarrhea
Measured: 3 weeks
Secondary outcomes (4)
Number and consistency of stools (normal, soft or unformed)
Measured: 3 weeks
Duration of traveler's diarrhea if occurred (# days)
Measured: 3 weeks
Presence of symptoms associated with TD (cramps, nausea, fever, blood in the stools, vomiting, bloating, flatulence, visceral pain)
Measured: 3 weeks
Need for rescue medication
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: because of low rate recruitment and the inability to reach the target expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Travelers' DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Investigators
- Mirella Pontello, Prof., Principal investigator, University of Milan, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005849
- Sponsor's protocol ID
- #09-prot-2-lal-01
- Acronym
- TD
- Status last verified
- Mar 2011
- First submitted
- 30 Oct 2009
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Probiotic Formula in the Prevention of Traveler's Diarrhea
- ClinicalTrials.gov ID
- NCT01005849
- Acronym / sponsor ID
- TD / #09-prot-2-lal-01
- Conditions
- Travelers' Diarrhea
- Keywords
- Probiotics, Traveler's diarrhea, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: because of low rate recruitment and the inability to reach the target expected
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Lallemand SASIndustry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protecflor | Experimental | Dietary Supplement: Protecflor |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protecflor1 Capsule to be taken once a day during the entire study period | Dietary supplement | Protecflor |
| Placebo1 Capsule to be taken once a day during the entire study period | Dietary supplement | Placebo |
Primary outcome
Occurence of traveler's diarrhea
Time frame: 3 weeks
4 secondary outcomes
Number and consistency of stools (normal, soft or unformed)
Time frame: 3 weeks
Duration of traveler's diarrhea if occurred (# days)
Time frame: 3 weeks
Presence of symptoms associated with TD (cramps, nausea, fever, blood in the stools, vomiting, bloating, flatulence, visceral pain)
Time frame: 3 weeks
Need for rescue medication
Time frame: 3 weeks
Results and safety
The study was stopped early (reason given: because of low rate recruitment and the inability to reach the target expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
Related trials for Travelers' Diarrhea
RecruitingPhase 4
Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct
Diarrhoea;Acute, Diarrhea Travelers
RecruitingEarly Phase 1
G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Travelers Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirella Pontello, Prof. principal investigator
University of Milan, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Protecflor in people with Travelers' Diarrhea, run by Lallemand SAS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: because of low rate recruitment and the inability to reach the target expected). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of traveler's diarrhea (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.