Effects of Probiotic VSL#3 on Expression of Small Intestinal Renin-angiotensin System

• Changes in epithelial permeability and glucose absorption capacity in vitro [ Time Frame: Change from baseline at 2 weeks after start of treatment. ] [ Designated as safety issue: No ]
  Mucosal biopsies are mounted in modified Ussing chambers. Permeability and glucose-absorption are assessed.
• Change in intestinal glucose absorption capacity in-vivo [ Time Frame: Change from baseline at 2 weeks after start of treatment. ] [ Designated as safety issue: No ]
  Glucose (75g) with an non-metaboliseble analogue (3-O-methyl-glucose; 2g) is instilled into the duodenum via a nasogastroduodenal tube (corresponding to an oral glucose tolerance test). Plasma glucose, 3OMG and insulin are assessed in 15 min periods over 2h.

Probiotics have become very popular and are by WHO defined as "Live microorganisms which when administered in adequate amounts confer a health benefit on the host". For example, probiotics have been shown to contribute to improvements of abdominal discomfort and intestinal inflammation. The main hypothesis behind the present study is that probiotics influences mucosal regulatory systems, particularly the actions of the hormone Angiotensin II locally in the intestinal mucosa.

• Biological: VSL#3

  The probiotic product VSL#3® comes in a powder (sachet) that is to be dissolved in half a glass of cold water before ingestion. Two sachets are ingested once daily over 2 weeks.

  Each dose (sachet) contains 450 billion live (lyophilized) lactic acid bacteria (in defined ratios of the following strains: Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus, Streptococcus thermophilus) and are delivered in a base of maltose and silicon dioxide.

• Biological: Placebo
  Two placebo sachets containing maltose and silicon dioxide are given once daily over 2 weeks.

• Active Comparator: VSL#3
  Intervention: Biological: VSL#3
• Placebo Comparator: Inactive treatment
  Intervention: Biological: Placebo

Inclusion Criteria:

• healthy volunteers of both sexes
• between 18 and 65 years of age.
• BMI between 18-25 kg/m2

Exclusion Criteria:

• Any drug abuse
• Use of prescription medication within the previous 14 days (with the exception of contraceptives)
• Pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control (e.g. IUD, barrier method, oral contraceptive, abstinence)
• In the investigator's judgement, clinically significant abnormalities at the screening examination or in the laboratory test results.