Original Article | Published:

A double-blind, placebo-controlled, randomized human study assessing the capacity of a novel galacto-oligosaccharide mixture in reducing travellers' diarrhoea

European Journal of Clinical Nutrition volume 64, pages 146152 (2010) | Download Citation

Subjects

Abstract

Background/Objectives:

Prebiotics have attracted interest for their ability to positively affect the colonic microbiota composition, thus increasing resistance to infection and diarrhoeal disease. This study assessed the effectiveness of a prebiotic galacto-oligosaccharide mixture (B-GOS) on the severity and/or incidence of travellers' diarrhoea (TD) in healthy subjects.

Subjects/Methods:

The study was a placebo-controlled, randomized, double blind of parallel design in 159 healthy volunteers, who travelled for minimum of 2 weeks to a country of low or high risk for TD. The investigational product was the B-GOS and the placebo was maltodextrin. Volunteers were randomized into groups with an equal probability of receiving either the prebiotic or placebo. The protocol comprised of a 1 week pre-holiday period recording bowel habit, while receiving intervention and the holiday period. Bowel habit included the number of bowel movements and average consistency of the stools as well as occurrence of abdominal discomfort, flatulence, bloating or vomiting. A clinical report was completed in the case of diarrhoeal incidence. A post-study questionnaire was also completed by all subjects on their return.

Results:

Results showed significant differences between the B-GOS and the placebo group in the incidence (P<0.05) and duration (P<0.05) of TD. Similar findings occurred on abdominal pain (P<0.05) and the overall quality of life assessment (P<0.05).

Conclusions:

Consumption of the tested galacto-oligosaccharide mixture showed significant potential in preventing the incidence and symptoms of TD.

Access optionsAccess options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

References

  1. (1990). Epidemiology of travellers' diarrhea and relative importance of various pathogens. Rev Infect Dis 12, S73–S79.

  2. , , (2002). Dietary oligofructose and inulin protect mice from enteric and systemic pathogens and tumour inducers. J Nutr 132, 472–477.

  3. Center for Disease Control and Prevention (CDC) (2008). Prevention of specific infectious diseases. In: CDC Health Information for International Travel. Atlanta, GA.

  4. , , (2002). Meta-analysis: the effect of probiotic administration on antibiotic associated diarrhea. Aliment Pharmacol Ther 16, 1461–1467.

  5. , , (2001). A study of fructooligosacharides in the prevention of travellers' diarrhea. Aliment Pharmacol Ther 15, 1139–1145.

  6. , , , , (2008). Prebiotic evaluation of a novel galacto-oligosaccharide mixture produced by the enzymatic activity of Bifidobacterium bifidum NCIM 41171, in healthy humans. Am J Clin Nutr 87 (Suppl, 3), S785–S791.

  7. (2001). Treatment of travellers' diarrhea. J Travel Med 8, S31–S33.

  8. , (1996). Persistent diarrhea in travellers. Clin Infect Dis 22, 124–128.

  9. , , (2005). Prebiotics and resistance to gastrointestinal infections. Br J Nutr 93, S31–S34.

  10. , (1995). Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr 125, 1401–1412.

  11. , , , , (2002). Efficacy of probiotic use in acute diarrhea in children: a meta-analysis. Dig Dis Sci 47, 2625–2634.

  12. , (2006). Prevention and management of travellers' diarrhea. Travel Med 52 (Suppl, 7), 289–302.

  13. , , , , (2000). Oligosaccharides in human milk: structural functional, and metabolic aspects. Ann Rev Nutr 20, 699–722.

  14. , , , , , et al. (2000). Etiology of travellers' diarrhea on a Caribbean Island. J Travel Med 7, 15–18.

  15. , (2001). Travellers' diarrhea epidemiology and clinical aspects. In: Dupont H, Steffen R (eds). Textbook of Travel Medicine and Health. BC Decker Inc, Hamilton: Canada. pp 151–159.

  16. , , , , (1994). Feeding of Bifidobacterium bifidum and Streptococcus thermophilus to infants in hospital for prevention of diarrhea and shedding of rotavirus. Lancet 344, 1046–1049.

  17. , , , , , et al. (2009). A galacto-oligosaccharide mixture, produced by the enzymatic activity of Bifidobacterium bifidum NCIMB 41171, reduces Salmonella Typhimurium infection in mice. J Med Microb 58, 37–48.

  18. , , , , (2009). Clinical trial: the effect of a trans-galactooligosacharide prebiotic on faecal microbiota and symptoms in irritable bowel syndrome. Aliment Pharmacol Ther 29, 508–518.

  19. , , , (1983). Epidemiology of diarrhea in travellers. JAMA 249, 1176–1180.

  20. , , , , , (1987). The effects of Bifidobacterium breve administration on Campylobacter enteritis. Acta Pediatr Jpn 29, 160–167.

  21. , , , (2005). A novel galactooligosaccharide mixture increases the bifidobacterial population numbers in a continuous in vitro fermentation system and in the proximal colon of pigs in vivo. J Nutr 135, 1726–1731.

  22. U.S. Food and Drug Administration (2008). Center for Food Safety and Applied Nutrition. Office of Food Additive Safety. Version 28 July, 2008. GRAS Notice No. CRN 000236. Internet: (accessed 06 November 2008).

  23. , , , , , (2000). Quinolone resistance in enterotoxigenic Escherichia coli causing diarrhea in travellers to India in comparison with other geographical areas. Antimicrob Agents Chemother 44, 1731–1733.

  24. , , , , (2008). Modulation of the fecal microflora profile and immune function by a novel trans-galactooligosacharide mixture (B-GOS) in healthy elderly volunteers. Am J Clin Nutr 88, 1438–1446.

  25. World Health Organization (2004). WHOQOL Study Protocol. WHO 2004 MNH7PSF/93.9.

Download references

Acknowledgements

Financial support was offered through a grant from Clasado Ltd. All data were analysed by Dr Drakoularakou.

Author information

Affiliations

  1. Department of Food Biosciences, The University of Reading, Reading, UK

    • A Drakoularakou
    • , R A Rastall
    •  & G R Gibson
  2. Clasado Ltd, 5 Canon Harnett Court, Wolverton Mill, Milton Keynes, UK

    • G Tzortzis

Authors

  1. Search for A Drakoularakou in:

  2. Search for G Tzortzis in:

  3. Search for R A Rastall in:

  4. Search for G R Gibson in:

Corresponding author

Correspondence to A Drakoularakou.

About this article

Publication history

Received

Revised

Accepted

Published

DOI

https://doi.org/10.1038/ejcn.2009.120

Further reading