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

NCT ID: NCT01635192

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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VSL#3

Group Type ACTIVE_COMPARATOR

VSL#3

Intervention Type 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.

Inactive treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Fändriks, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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ProGlucose-1

Identifier Type: -

Identifier Source: org_study_id