Intestinal Barrier Function and Probiotics.
Condition: Intestinal Permeability; Challenge Test; Intestinal Health; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Rationale: Enterotoxigenic Escherichia coli (ETEC) bacteria adhere to the mucosa of the
      proximal intestines. There it produces an toxin which presents a local and relevant challenge
      to the intestines. This is proposed to give an indication of general resistance and/or the
      local resistance of the intestines. The sequel of events of mucosal inflammation will be
      characterized in this study. In addition we will evaluate the effects of probiotics by
      comparing the infection symptoms and by measuring faecal weight and mucus in faeces.

      Objective: The main objective of this study is to investigate the effect of probiotics on the
      sequels of ETEC administration as intestinal permeability, inflammation and clinical signs as
      total faecal output, relative faecal dry weight and mucin excretion in faeces. In addition,
      the sequels of the mucosal inflammation will be characterized and biomarkers will be
      searched.
    

Detailed description: 
      Study population: 36 Healthy male volunteers; age >= 21 and <= 40 years. Intervention: One
      group receives twice daily two sachets containing 450 billion live freeze-dried lactic acid
      bacteria per sachet and the other group receives twice daily two placebo sachets.

      Study design: The study is designed as a randomized, parallel, placebo-controlled,
      double-blind study. Study substance (probiotics) and placebo will be given during 4 weeks.

      Main study parameters/endpoints: The main study parameter is the percent change in faecal dry
      weight and total faecal output between the probiotics group and the placebo group. In
      addition, intestinal permeability, inflammation and other clinical symptoms will be
      evaluated.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: In this study healthy male volunteers will be challenged with an attenuated ETEC
      strain after three weeks of either probiotics or placebo. This infection will lead to a mild
      traveller's diarrhoea in the subjects during approximately three days maximally. Sequels of
      this infection and the effects of commercially available probiotics compared to placebo will
      be followed up. The subjects will therefore collect their faeces on several days, record
      their defecation pattern and gastro-intestinal complaints during four weeks, undergo a
      physical examination and five venapunctions, and visit our facilities in total on 8 days
      (excluding two pre-study visits). The oral administration of probiotics in a healthy
      population is not associated with risk.
    

Intervention name(s): Priobiotic supplement VSL#3
Intervention type(s): Dietary Supplement
Intervention description(s): four weeks, twice daily two sachets of VSL#3, a priobitics mixture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: intestinal health; probiotics; inflammation; biomarkers