Completed

NCT Number: NCT01635192

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital

Gothenburg, SE41345, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VSL#3

Biological

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

Biological

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

Primary outcomes

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.

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.

Secondary outcomes

Changes in epithelial permeability and glucose absorption capacity in vitro

Time frame: Change from baseline at 2 weeks after start of treatment.

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.

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.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

Sahlgrenska University Hospital

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jul 9, 2012
Registry last updated: Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.