A study of a food supplement, Galacto-OligoSaccaride (GOS) in reducing travellers diarrhea
| ISRCTN | ISRCTN74669614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74669614 |
| Clinical Trials Information System (CTIS) | 2014-000430-27 |
| Protocol serial number | 1 |
| Sponsor | Reiseklinikken - Oslo Travel Clinic (Norway) |
| Funders | Reiseklinikken-Oslo Travel Clinic (Norway), Clasado Ltd (UK) provided study material, pastilles containing GOS or placebo free of charge |
- 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
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
Scientific
Reiseklinikken
St Olavs plass 3
Oslo
N-0165
Norway
| Phone | +47 90 89 09 64 |
|---|---|
| hasle@reiseklinikken.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Placebo-controlled randomized double blind study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | galacto-oligosaccaride |
| Primary outcome measure(s) |
1. Incidence of traveller's diarrhea |
| Key secondary outcome measure(s) |
1. Complications, treatment and hospitalisation. |
| Completion date | 15/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
N-0165
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2017 | 21/01/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/01/2019: Publication reference added
