NCT01635192

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Göteborg University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• the Local Renin-angiotensin System (RAS) in Small Intestinal Mucosa in Man

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-07-09
• Last updated: 2021-10-15

Locations

1 site across 1 country: Sweden