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

Eur J Clin Nutr. 2010 Feb;64(2):146-52. doi: 10.1038/ejcn.2009.120. Epub 2009 Sep 16.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdominal Pain / drug therapy*
  • Abdominal Pain / microbiology
  • Adult
  • Defecation / drug effects
  • Diarrhea / drug therapy*
  • Diarrhea / epidemiology
  • Diarrhea / etiology
  • Double-Blind Method
  • Dysentery / complications
  • Dysentery / drug therapy*
  • Feces
  • Female
  • Flatulence / drug therapy
  • Flatulence / microbiology
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Incidence
  • Male
  • Oligosaccharides / therapeutic use*
  • Prebiotics*
  • Quality of Life
  • Severity of Illness Index
  • Travel*
  • Vomiting / drug therapy
  • Vomiting / microbiology

Substances

  • Gastrointestinal Agents
  • Oligosaccharides
  • Prebiotics