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

NCT01635192 | Completed Early Phase 1

• 1 other identifier: ProGlucose-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

renin; angiotensin; probiotic; glucose absorption; intestinal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in epithelial permeability and glucose absorption capacity in vitro

  Change from baseline at 2 weeks after start of treatment.

• Change in intestinal glucose absorption capacity in-vivo

  Change from baseline at 2 weeks after start of treatment.

Study Arms (2)

VSL#3

ACTIVE COMPARATOR

Biological: VSL#3

Inactive treatment

PLACEBO COMPARATOR

Biological: Placebo

Interventions

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.

VSL#3

Placebo BIOLOGICAL

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

Inactive treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers of both sexes
• between 18 and 65 years of age.
• BMI between 18-25 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital

Gothenburg, SE41345, Sweden

Location

Study Officials

• Lars Fändriks, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 9, 2012
• Study Start: December 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 15, 2021

Record last verified: 2014-05

Locations

SE (1)