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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74669614

Enrollment

800

Registered

2014-02-11

Start date

2014-03-15

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traveller's diarrhea Infections and Infestations

Interventions

Ingesting pastilles containing galacto-oligosaccaride or placebo (maltodextrin) Pastilles containing galacto-oligosaccharide (B-GOS, Bimuno), 0.9 g per pastille, or placebo (maltodext

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Any intestinal disease 2. Antibiotic or probiotics before travelling

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Norway

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026