A study of a food supplement, Galacto-OligoSaccaride (GOS) in reducing travellers diarrhea

ISRCTN	ISRCTN74669614
DOI	https://doi.org/10.1186/ISRCTN74669614
EudraCT/CTIS number	2014-000430-27
Secondary identifying numbers	1

Submission date: 28/01/2014
Registration date: 11/02/2014
Last edited: 21/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Travellers diarrhea (TD) affects nearly one third of all travellers to tropical and subtropical regions. A small study with 159 participants comparing a galacto-oligosaccaride (GOS) and placebo (dummy) found that the incidence of travellers diarrhea was reduced by 39%. We want to carry out a larger study to confirm this important finding.

Who can participate?
The participants will be recruited among the clients of Reiseklinikken (Oslo Travel Clinic), and all healthy travellers above 5 years of age, who are going to travel 5-15 days in an area with a high risk of TD, may be included.

What does the study involve?
The participants are randomly allocated to either eat pastilles containing GOS or placebo from five days before departure and during the whole travel. During travel they will have to fill a diarrhea journal, indicating diarrhea, number of bowel movements, fever, pain, blood in stool and treatment during the travel. Those who still have diarrhea after returning home will be offered a free examination and follow-up at Reiseklinikken (Oslo Travel Clinic).

What are the possible benefits and risks of participating?
Participants receiving galacto-oligosaccaride (GOS) may have a reduced risk of contracting traveler's diarrhea.

Where is the study run from?
The study will be run from Reiseklinikken (Oslo Travel Clinic), Norway.

When is the study starting and how long is it expected to run for?
The study started in March 2014, and will run until 1600 participants have returned their forms, and this is expected to be by July 2014.

Who is funding the study?
Reiseklinikken-Oslo Travel Clinic (Norway) and Clasado Ltd (UK) provided study material and pastilles containing GOS or placebo free of charge.

Who is the main contact?
Gunnar Hasle
hasle@reiseklinikken.com

Contact information

Dr Gunnar Hasle
Scientific

Reiseklinikken
St Olavs plass 3
Oslo
N-0165
Norway

Phone	+47 90 89 09 64
Email	hasle@reiseklinikken.com

Study information

Study design	Placebo-controlled randomized double blind study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A placebo-controlled, randomized, double blind study of a galacto-oligosaccharide in reducing travellers diarrhea
Study acronym	GOS
Study objectives	Traveller's diarrhea: Definition of diarrhea (WHO) - The passage of 3 or more loose or liquid stools per day, or more frequently than is normal for the individual. A galacto-oligosaccaride (GOS) may reduce the risk of contracting traveller's diarrhea (TD).
Ethics approval(s)	Norwegian Ethical Committee, Regional Committees for Medical and Health Research Ethics (REK) - approval pending
Health condition(s) or problem(s) studied	Traveller's diarrhea
Intervention	Ingesting pastilles containing galacto-oligosaccaride or placebo (maltodextrin) Pastilles containing galacto-oligosaccharide (B-GOS, Bimuno), 0.9 g per pastille, or placebo (maltodextrin), provided by Bimuno. Dosage: Between 5-12 years one pastille per day, from 12-16 years two pastilles per day, and over 16 years three pastilles per day. Start 5 days prior to the travel, continue until the return day. The form should be returned 7 days after return home. There will be no follow up after this, except for those who still have diarrhea, which will be followed up like ordinary patients, although free, as a benefit for the participants.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	galacto-oligosaccaride
Primary outcome measure	1. Incidence of traveller's diarrhea 2. Number of bowel movements The incidence of diarrhea, i.e., > 3 loose stools per day, number of bowel movements will be registered by the patients every day, until one week after return. Later cases of diarrhea will unlikely have been contracted during the travel. Concerning pain we have planned a 'yes' or 'no' registration, as degree of pain poorly corresponds with the severity of TD.
Secondary outcome measures	1. Complications, treatment and hospitalisation. 2. Result of microbiological examination of those who still have diarrhea after return. These are to be considered as ordinary patients. Apart from the routine examinations (i.e., Salmonella, Shigella, Yersinia and Campylobacter) we will perform an Enterotoxigenic Escherichia coli polymerase chain reaction (ETEC PCR), free for the patients. The participants will have given informed consent that the results from these tests may be used anonymously as results in the study.
Overall study start date	15/03/2014
Completion date	15/07/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	800
Key inclusion criteria	1. Healthy travellers above 5 years of age travelling 5-15 days to countries with a high risk of TD 2. Who sign an informed consent to participate, or, if under 18 years have parents who can sign the consent.
Key exclusion criteria	1. Any intestinal disease 2. Antibiotic or probiotics before travelling
Date of first enrolment	15/03/2014
Date of final enrolment	15/07/2014

Locations

Countries of recruitment

Norway

Study participating centre

Reiseklinikken

Oslo
N-0165
Norway

Sponsor information

Reiseklinikken - Oslo Travel Clinic (Norway)
Hospital/treatment centre

St Olavs plass 3
oslo
N-0165
Norway

Phone	+47 22 99 15 80
Email	hasle@reiseklinikken.com
Website	http://www.reiseklinikken.no

Funders

Funder type

Hospital/treatment centre

Reiseklinikken-Oslo Travel Clinic (Norway)

No information available

Clasado Ltd (UK) provided study material, pastilles containing GOS or placebo free of charge