title: A double-blind, placebo-controlled, randomized human study assessing the capacity of a novel galacto-oligosaccharide mixture in reducing travellers' diarrhoea.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Department of Food Biosciences, The University of Reading, Reading, UK. a.drakoularakou@gmail.com
authors.forename: A
authors.initials: A
authors.lastname: Drakoularakou
authors.forename: G
authors.initials: G
authors.lastname: Tzortzis
authors.forename: R A
authors.initials: RA
authors.lastname: Rastall
authors.forename: G R
authors.initials: GR
authors.lastname: Gibson
mesh_terms: D015746:Abdominal Pain / Q000188:drug therapy* / Q000382:microbiology; D000328:Adult; D003672:Defecation / Q000187:drug effects; D003967:Diarrhea / Q000188:drug therapy* / Q000453:epidemiology / Q000209:etiology; D004311:Double-Blind Method; D004403:Dysentery / Q000150:complications / Q000188:drug therapy*; D005243:Feces; D005260:Female; D005414:Flatulence / Q000188:drug therapy / Q000382:microbiology; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D008297:Male; D009844:Oligosaccharides / Q000627:therapeutic use*; D056692:Prebiotics; D011788:Quality of Life; D012720:Severity of Illness Index; D014195:Travel; D014839:Vomiting / Q000188:drug therapy / Q000382:microbiology
chemical_list: D005765:Gastrointestinal Agents; D009844:Oligosaccharides; D056692:Prebiotics