| Trial ID: | L0992 |
| Source ID: | NCT02972567
|
| Associated Drug: |
Lactobacillus spp
|
| Title: |
Evaluation of the Effects of a L.Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease
|
| Acronym: |
PROSIR
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Metabolic Syndrome X
|
| Interventions: |
Dietary Supplement: Lactobacillus spp|Dietary Supplement: Control
|
| Outcome Measures: |
Change from basal plasma lipopolysaccharide (LPS) at 12 weeks|Change from basal Blood pressure at 12 weeks|Change from basal HOMA ( homeostatic model assessment ) index at 12 weeks|Change from basal plasma cholesterol level (total, LDL and HDL) at 12 weeks|Change from basal plasma Inflammatory markers (sVCAM, sICAM, myeloperoxidase selectin, adiponectin, plasminogen activator inhibitor and resistin, and interleukines Il-6, Il-8, tumor necrosis factor, HGF, leptin and Multicopper oxidase-1) at 12 weeks|Change from basal Hepatic Steatosis markers (arginase, prolidase and RBP-4(Retinol binding protein-4)) at 12 weeks|Changes from basal fecal microbiota at 12 weeks
|
| Sponsor/Collaborators: |
Biosearch S.A.|Universidad de Granada|Complejo Hospitalario de Jaen
|
| Gender: |
All
|
| Age: |
18 Years to 65 Years ?? (Adult, Older Adult)
|
| Phases: |
Not applicable
|
| Enrollment: |
60
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
May 2016
|
| Completion Date: |
December 2017
|
| Results First Posted: |
--
|
| Last Update Posted: |
July 13, 2020
|
| Locations: |
Complejo Hospitalario Universitario de Jaen, Jaen, Spain
|
| URL: |
https://ClinicalTrials.gov/show/NCT02972567
|
