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

G

Göteborg University

Status and phase

Completed
Early Phase 1

Conditions

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

Treatments

Biological: Placebo
Biological: VSL#3

Study type

Interventional

Funder types

Other

Identifiers

NCT01635192
ProGlucose-1

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

24 participants in 2 patient groups, including a placebo group

VSL#3
Active Comparator group
Treatment:
Biological: VSL#3
Inactive treatment
Placebo Comparator group
Treatment:
Biological: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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