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Can a galacto-oligosaccharide reduce the risk of traveller's diarrhoea? A placebo-controlled, randomized, double-blind study.
J Travel Med. 2017 Sep 01; 24(5)JT

Abstract

Background

Diarrhoea is a common medical problem affecting travellers to Asia, Africa and Latin America. The use of prophylactic antimicrobial agents may increase the risk of contracting resistant bacteria. Findings indicate that oligosaccharides, i.e. carbohydrate chains of 3-10 monosaccharides, reduce the risk of diarrhoea.

Methods

We performed a placebo-controlled, double-blind study of a galacto-oligosaccharide, B-GOS (Bimuno®, Clasado Ltd, Milton Keynes UK), vs placebo for participants travelling to countries with a high/intermediate risk of diarrhoea for 7-15 days. The participants ingested 2.7g of B-GOS daily from 5 days prior to departure throughout the travel period, and returned a questionnaire, with a diarrhoea log, after their return. The case definition of diarrhoea was three or more loose stools per day.

Results

Of 523 enrolled subjects, 334 travellers managed to comply per protocol (PP), 349 followed the protocol at least until the onset of diarrhoea (conditionally evaluable, CE), and 408 followed the protocol with fewer than 5 days of deviance from the protocol (intention to treat, ITT). There was a significant reduction of diarrhoea incidence in the PP group (odds ratio = 0.56, P = 0.03), while the effect in the CE group was non-significant (OR = 0.65, P = 0.08). No significant effect was found during the first 7 days after starting with B-GOS, but from day 8 there was a significant effect in both the PP and CE groups (OR = 0.47, P = 0.02 and OR = 0.53, P = 0.03, respectively). The entire effect was seen in 1-day (i.e. self-limiting) diarrhoea (PP: OR = 0.25, P = 0.004). There was no effect on duration or the number of bowel movements during diarrhoea. The severity of diarrhoea was not affected.

Conclusions

B-GOS reduces the risk of diarrhoea lasting 1 day. The protection seemed to start after a week of treatment with B-GOS. Strict compliance is crucial. The treatment is environmentally friendly and without adverse effects.

Authors+Show Affiliations

Reiseklinikken, St Olavs Plass 3, 0165 Oslo.Reiseklinikken, St Olavs Plass 3, 0165 Oslo.Institute of Health and Society, University of Oslo, Frederik Holsts hus, Kirkeveien 166, 0450 Oslo.Department of Laboratory Medicine, Medical Microbiology, Vestre Viken Hospital Trust, Drammen and Institute of Clinical Medicine, University of Oslo, Dronninggata 28, 3004 Oslo, Norway.Reiseklinikken, St Olavs Plass 3, 0165 Oslo.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28931149

Citation

Hasle, Gunnar, et al. "Can a Galacto-oligosaccharide Reduce the Risk of Traveller's Diarrhoea? a Placebo-controlled, Randomized, Double-blind Study." Journal of Travel Medicine, vol. 24, no. 5, 2017.
Hasle G, Raastad R, Bjune G, et al. Can a galacto-oligosaccharide reduce the risk of traveller's diarrhoea? A placebo-controlled, randomized, double-blind study. J Travel Med. 2017;24(5).
Hasle, G., Raastad, R., Bjune, G., Jenum, P. A., & Heier, L. (2017). Can a galacto-oligosaccharide reduce the risk of traveller's diarrhoea? A placebo-controlled, randomized, double-blind study. Journal of Travel Medicine, 24(5). https://doi.org/10.1093/jtm/tax057
Hasle G, et al. Can a Galacto-oligosaccharide Reduce the Risk of Traveller's Diarrhoea? a Placebo-controlled, Randomized, Double-blind Study. J Travel Med. 2017 Sep 1;24(5) PubMed PMID: 28931149.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Can a galacto-oligosaccharide reduce the risk of traveller's diarrhoea? A placebo-controlled, randomized, double-blind study. AU - Hasle,Gunnar, AU - Raastad,Ragnhild, AU - Bjune,Gunnar, AU - Jenum,Pål A, AU - Heier,Lise, PY - 2017/07/12/accepted PY - 2017/9/21/entrez PY - 2017/9/21/pubmed PY - 2018/5/16/medline KW - Diarrhoea KW - galacto-oligosaccharide KW - randomized clinical trial KW - traveller's diarrhoea JF - Journal of travel medicine JO - J Travel Med VL - 24 IS - 5 N2 - Background: Diarrhoea is a common medical problem affecting travellers to Asia, Africa and Latin America. The use of prophylactic antimicrobial agents may increase the risk of contracting resistant bacteria. Findings indicate that oligosaccharides, i.e. carbohydrate chains of 3-10 monosaccharides, reduce the risk of diarrhoea. Methods: We performed a placebo-controlled, double-blind study of a galacto-oligosaccharide, B-GOS (Bimuno®, Clasado Ltd, Milton Keynes UK), vs placebo for participants travelling to countries with a high/intermediate risk of diarrhoea for 7-15 days. The participants ingested 2.7g of B-GOS daily from 5 days prior to departure throughout the travel period, and returned a questionnaire, with a diarrhoea log, after their return. The case definition of diarrhoea was three or more loose stools per day. Results: Of 523 enrolled subjects, 334 travellers managed to comply per protocol (PP), 349 followed the protocol at least until the onset of diarrhoea (conditionally evaluable, CE), and 408 followed the protocol with fewer than 5 days of deviance from the protocol (intention to treat, ITT). There was a significant reduction of diarrhoea incidence in the PP group (odds ratio = 0.56, P = 0.03), while the effect in the CE group was non-significant (OR = 0.65, P = 0.08). No significant effect was found during the first 7 days after starting with B-GOS, but from day 8 there was a significant effect in both the PP and CE groups (OR = 0.47, P = 0.02 and OR = 0.53, P = 0.03, respectively). The entire effect was seen in 1-day (i.e. self-limiting) diarrhoea (PP: OR = 0.25, P = 0.004). There was no effect on duration or the number of bowel movements during diarrhoea. The severity of diarrhoea was not affected. Conclusions: B-GOS reduces the risk of diarrhoea lasting 1 day. The protection seemed to start after a week of treatment with B-GOS. Strict compliance is crucial. The treatment is environmentally friendly and without adverse effects. SN - 1708-8305 UR - https://www.unboundmedicine.com/medline/citation/28931149/Can_a_galacto_oligosaccharide_reduce_the_risk_of_traveller's_diarrhoea_A_placebo_controlled_randomized_double_blind_study_ L2 - https://academic.oup.com/jtm/article-lookup/doi/10.1093/jtm/tax057 DB - PRIME DP - Unbound Medicine ER -