Condition category
Infections and Infestations
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
01/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.winclove.nl/nieuws12.htm

Contact information

Type

Scientific

Primary contact

Dr N Zijlstra-Remon

ORCID ID

Contact details

Polikliniek tropische geneeskunde
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
N.Zijlstra-Remon@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

A relative reduction of 50% in the occurence of traveller's diarrhoea.

Ethics approval

Approval received from the local ethics board (Medisch Ethische Commissie of the AMC) on the 25th January 2007 (ref: MEC 06/291 # 07.17.0154).

Study design

Randomised, placebo controlled, parallel group, double blinded, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Traveller's diarrhoea, prebiotics, lactobacillus, bifidobacterium

Intervention

Ecologic Travel ®, a multispecies probiotic product versus a placebo. Intervention consists of one sachet probiotics in powder form containing the following strains: Bifidobacterium bifidum, Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus salivarius and Lactococcus lactis (minimal number of cells: 1 x 10^9 cfu/g).

Intervention type

Drug

Phase

Not Specified

Drug names

Ecologic Travel ®

Primary outcome measures

1. Consistency of stools according to Bristol scale
2. Frequency of stools

Secondary outcome measures

Duration of traveller's diarrhoea

Overall trial start date

12/01/2007

Overall trial end date

01/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both male and female adults (+18)
2. Travelling to high risk area's for Traveller's Diarrhoea (TD) (Middle East, Asia, South and Central America, North Africa)
3. Duration of travelling: min. seven days, max. 28 days
4. People who experienced TD before
5. All new travellers to high risk areas

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

800

Participant exclusion criteria

1. Use of antibiotics until two weeks before leaving
2. Use of laxatives, acid blockers and diarrhoea inhibitors
3. Persons who already have complaints about their stomach and/or intestines
4. Irritable Bowel Syndrome (IBS)/Irritable Bowel Disease (IBD) and stoma patients
5. Pregnant or breastfeeding women
6. Patients with a serious disturbed or fragile/weak immune system (according to the Dutch National Coordination Center for Travelers' Health Advice [LCR] criteria)
7. Use of probiotics two weeks before start of journey
8. Frequent traveller's to high risk area's who never had TD complaints

Recruitment start date

12/01/2007

Recruitment end date

01/11/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Polikliniek tropische geneeskunde
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Centre for Tropics
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/#http://www.amc.uva.nl/

Funders

Funder type

Industry

Funder name

Winclove Bio Industries B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes