Viewing Study NCT02622867


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Study NCT ID: NCT02622867
Status: COMPLETED
Last Update Posted: 2015-12-07
First Post: 2015-11-18
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Lactobacillus Plantarum 3547 Effects Over Inflammatory and Immunologic Markers
Sponsor: Instituto de Investigación Hospital Universitario La Paz
Organization:

Study Overview

Official Title: Nutritional Intervention Clinical Trial to Evaluate the Lactobacillus Plantarum 3547 Probiotic Effects Over Different Inflammation and Immune System Markers in a Group of Healthy Middle-aged People
Status: COMPLETED
Status Verified Date: 2015-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to evaluate the effects of the probiotic Lactobacillus plantarum 3547 over different inflammation and immune system markers on a healthy middle-aged group.
Detailed Description: In this randomized double blind controlled trial, a group of healthy middle-aged people (45 to 65 years old) had a nutritional intervention to evaluate the Lactobacillus plantarum 3547 probiotic effects over different inflammation and immune system markers, the experimental group took the experimental supplement (Lactobacillus plantarum 3547) during one period of parallel study (12 weeks), the volunteers consumed 1 capsule/daily with Lactobacillus plantarum 3547 (10x109 cfu/d) immediately after finishing their meal, the capsule contains: 77 mg probiotic Lp3547 and 390 mg maltodextrins. The control group took the control supplement (Maltodextrin) during one period of parallel study (12 weeks), volunteers consumed 1 daily capsule of maltodextrin without Lactobacillus plantarum 3547 (Placebo) immediately after finishing their meal. (The capsule contains 425 mg of maltodextrin)

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: