Effect of probiotic supplement (L. plantarum strain TENSIA) on healthy volunteers

Phase 1

Completed

• Conditions: Improving intestinal flora; Digestive System

• Registration Number: ISRCTN24502121
• Lead Sponsor: BioCC OÜ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-24
• Study Completion: 2011-11-14
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Wish to participate in the study
2. Aged 18 years and over
3. Healthy (i.e., no known health problems and no medical conditions that require drug therapy)
4. Signed informed consent

Exclusion Criteria

1. History of any gastrointestinal disease
2. Use of any antimicrobial drug within last month
3. Use of any regular concomitant medication, including medical preparations
4. Food allergy
5. Pregnancy or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Adverse gastrointestinal effects<br> 2. Negative shifts in values of systemic inflammation markers<br> 3. Changes in lipid metabolism<br> 4. Changes in key immunological parameters and markers of oxidative stress<br> 5. Reduction of blood pressure<br> Measured pre intervention, at the end of the intervention and also 1 week post intervention<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Changes in fecal microflora<br> 2. Persistence of ingested probiotic strain for 1 week<br>