Can a galacto-oligosaccharide reduce the risk of traveller's diarrhoea? A placebo-controlled, randomized, double-blind study.

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 (BimunoVR, 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.