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

NCT01635192 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-10-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Göteborg University

    lead OTHER

Principal Investigators

  • Lars Fändriks, MD, PhD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01635192 on ClinicalTrials.gov