Condition category
Infections and Infestations
Date applied
28/01/2014
Date assigned
11/02/2014
Last edited
11/02/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Traveller’s 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 traveller’s 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gunnar Hasle

ORCID ID

Contact details

Reiseklinikken
St Olavs plass 3
Oslo
N-0165
Norway
+47 90 89 09 64
hasle@reiseklinikken.com

Additional identifiers

EudraCT number

2014-000430-27

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

A placebo-controlled, randomized, double blind study of a galacto-oligosaccharide in reducing traveller’s diarrhea

Acronym

GOS

Study hypothesis

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

Norwegian Ethical Committee, Regional Committees for Medical and Health Research Ethics (REK) - approval pending

Study design

Placebo-controlled randomized double blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

galacto-oligosaccaride

Primary outcome measures

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 trial start date

15/03/2014

Overall trial end date

15/07/2014

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Any intestinal disease
2. Antibiotic or probiotics before travelling

Recruitment start date

15/03/2014

Recruitment end date

15/07/2014

Locations

Countries of recruitment

Norway

Trial participating centre

Reiseklinikken
Oslo
N-0165
Norway

Sponsor information

Organisation

Reiseklinikken - Oslo Travel Clinic (Norway)

Sponsor details

St Olavs plass 3
oslo
N-0165
Norway
+47 22 99 15 80
hasle@reiseklinikken.com

Sponsor type

Hospital/treatment centre

Website

http://www.reiseklinikken.no

Funders

Funder type

Hospital/treatment centre

Funder name

Reiseklinikken-Oslo Travel Clinic (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

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