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

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.

Study Overview

• Status: Completed
• Conditions: the Local Renin-angiotensin System (RAS) in Small Intestinal Mucosa in Man
• Intervention / Treatment: Biological: VSL#3; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, SE41345
    • Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VSL#3	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.
Placebo Comparator: Inactive treatment	Biological: Placebo; Two placebo sachets containing maltose and silicon dioxide are given once daily over 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in mucosal expression of components of renin-angiotensin (particularly ACE1, AT1-receptor, AT2-receptor)	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.	Change from baseline in protein expressions after 2 weeks of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in epithelial permeability and glucose absorption capacity in vitro	Mucosal biopsies are mounted in modified Ussing chambers. Permeability and glucose-absorption are assessed.	Change from baseline at 2 weeks after start of treatment.
Change in intestinal glucose absorption capacity in-vivo	Glucose (75g) with an non-metabolisable 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.	Change from baseline at 2 weeks after start of treatment.

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Lars Fändriks, MD, PhD, Göteborg University

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: June 28, 2012
• First Submitted That Met QC Criteria: July 3, 2012
• First Posted (Estimate): July 9, 2012

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: probiotic; glucose absorption; renin; angiotensin; intestinal
• Other Study ID Numbers: ProGlucose-1