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

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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635192
• Other study ID #: ProGlucose-1
• Status: Completed
• Phase: Early Phase 1
• Start date: December 2011
• Est. completion date: July 2013

Study information

• Verified date: May 2014
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Sweden	Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.