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

Early Phase 1

Completed

• Conditions: the Local Renin-angiotensin System (RAS) in Small Intestinal Mucosa in Man
• Interventions: Biological: Placebo; Biological: VSL#3

• Registration Number: NCT01635192
• Lead Sponsor: Göteborg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-09
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-05
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inactive treatment	Placebo	-
VSL#3	VSL#3	-

Primary Outcome Measures

Name	Time	Method
The change in mucosal expression of components of renin-angiotensin (particularly ACE1, AT1-receptor, AT2-receptor)	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 Outcome Measures

Name	Time	Method
Changes in epithelial permeability and glucose absorption capacity in vitro	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	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.

Trial Locations

Locations (1)

Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital; 🇸🇪 Gothenburg, Sweden