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
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- The change in mucosal expression of components of renin-angiotensin (particularly ACE1, AT1-receptor, AT2-receptor)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
VSL#3
Intervention: VSL#3 (Biological)
Inactive treatment
Intervention: Placebo (Biological)
Outcomes
Primary Outcomes
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.
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 Outcomes
- 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.)