Effects of Probiotic VSL#3 on Expression of Small Intestinal Renin-angiotensin System
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.
the Local Renin-angiotensin System (RAS) in Small Intestinal Mucosa in Man
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Effects of Probiotic VSL#3 on Expression of Small Intestinal Mucosal Renin-angiotensin System and Glucose Absorption in Man - a Doubleblind, Randomized Parallel Arm Placebo Controlled Exploratory Study in Healthy Volunteers|
- The change in mucosal expression of components of renin-angiotensin (particularly ACE1, AT1-receptor, AT2-receptor) [ Time Frame: Change from baseline in protein expressions after 2 weeks of treatment. ] [ Designated as safety issue: No ]Mucosal biopsies from jejunum are sampled via endoscopy immediately before (baseline) and at the end of the 2 weeks treatment period. Protein expressions are assessed by western blotting and the subject acts as its own control.
- 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.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: 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.
|Placebo Comparator: Inactive treatment||
Two placebo sachets containing maltose and silicon dioxide are given once daily over 2 weeks.
|Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital|
|Gothenburg, Sweden, SE41345|
|Principal Investigator:||Lars Fändriks, MD, PhD||Göteborg University|