Probiotics in the prevention of traveller's diarrhoea

ISRCTN	ISRCTN76793515
DOI	https://doi.org/10.1186/ISRCTN76793515
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr N Zijlstra-Remon
Scientific

Polikliniek tropische geneeskunde
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Email	N.Zijlstra-Remon@amc.uva.nl

Study design	Randomised, placebo controlled, parallel group, double blinded, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Probiotics in the prevention of traveller's diarrhoea
Study objectives	A relative reduction of 50% in the occurence of traveller's diarrhoea.
Ethics approval(s)	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).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ecologic Travel ®
Primary outcome measure	1. Consistency of stools according to Bristol scale 2. Frequency of stools
Secondary outcome measures	Duration of traveller's diarrhoea
Overall study start date	12/01/2007
Completion date	01/11/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	800
Key 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
Key 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
Date of first enrolment	12/01/2007
Date of final enrolment	01/11/2007

Polikliniek tropische geneeskunde

Amsterdam
1105 AZ
Netherlands

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

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

Website	http://www.amc.uva.nl/#http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Industry

Winclove Bio Industries B.V. (The Netherlands)

No information available

Academic Medical Centre (AMC) (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

20/08/2021: Proactive update review. No publications found. Search options exhausted.