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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01635192
First received: June 28, 2012
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
the Local Renin-angiotensin System (RAS) in Small Intestinal Mucosa in Man
 Biological: VSL#3
Biological: Placebo
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Basic Science
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

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Changes in epithelial permeability and glucose absorption capacity in vitro [ Time Frame: Change from baseline at 2 weeks after start of treatment. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Glucose (75g) with an non-metaboliseble 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.


Enrollment: 24
Study Start Date: December 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635192

Locations
Sweden
Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital
Gothenburg, Sweden, SE41345
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Lars Fändriks, MD, PhD Göteborg University
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01635192     History of Changes
Other Study ID Numbers: ProGlucose-1
Study First Received: June 28, 2012
Last Updated: July 3, 2012
Health Authority: Sweden: Swedish Ethical Review Board

Keywords provided by Göteborg University:
renin
angiotensin
probiotic
glucose absorption
intestinal

ClinicalTrials.gov processed this record on May 23, 2013