Lactobacillus Plantarum 3547 Effects Over Inflammatory and Immunologic Markers

December 2, 2015 updated by: Instituto de Investigación Hospital Universitario La Paz

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • La Paz University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women from 45 to 65 years old;
  • Body Mass Index (BMI) ≥ 18,5 and < 40 kg/m2
  • Signed informed consent.
  • Adequate cultural level and understanding for the clinical trial.
  • Free of infections at baseline

Exclusion Criteria:

  • Individuals with severe diseases (hepatic, kidney, cancer…);
  • Individuals with diagnosed metabolic syndrome, diabetes and/or hyperthyroidism;
  • Individuals with chronic intestinal pathologies (Gastritis, Colitis, Irritable Bowel Syndrome, Pseudomembranous Colitis, Crohn's disease…);
  • Individuals with dementia, mental disease or low cognitive function;
  • Individuals with autoimmune diseases and/or under treatment with corticosteroids and/or immunosuppressants;
  • Individuals with major surgeries during the last month or gastrointestinal surgery in the last 3 months;
  • Individuals treated with oral antibiotics during two weeks prior to the beginning of the study;
  • Individuals undergoing dietary restriction and/or pharmacological treatment for the decrease of body weight 2 months prior to the beginning of the study;
  • Individuals who intend to quit smoking during the next 20 weeks;
  • Women that consume oral contraceptive;
  • Pregnant women or breastfeeding;
  • Individuals with intensive physical activity (> 2 hours, more than 3 times per week);
  • Individuals that consume antioxidant supplement, drugs, ω-3 supplements, vitamins, minerals, prebiotics or/and probiotics during the 2 weeks prior to the beginning of the study and that will not eliminate their consumption during the study;
  • Individuals with regular consumption (> 3 servings per week) of fermented foods (yogurt, actimel, kefir, blue cheese…) and/or use of other prebiotics and not to accept suppress their consumption during the study;
  • Individuals with increased alcohol consumption >30g/day (equivalent to 300 ml of wine, about 3 beers or a cup (75 ml) of whiskey , brandy , anise, etc);
  • Individuals with regular use of laxatives (> 2 a week) and (Laxbene, Miralax, Dulco - Lax, etc.) and does not accept suppress its consumption during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lactobacillus plantarum 3547
1 capsule/daily during 12 weeks with Lactobacillus plantarum 3547 (10x109 cfu/d). The capsule contains 77 mg probiotic Lp3547 and 390 mg maltodextrin
Other: Lactobacillus plantarum 3547
During one period of parallel study (12 weeks) volunteers consumed 1 capsule/daily with Lactobacillus plantarum 3547 immediately after finishing their meal.
Placebo Comparator: Maltodextrin
1 daily capsule of maltodextrin (425 mg) during 12 weeks
Dietary supplement: Maltodextrin
During one period of parallel study (12 weeks), volunteers will consume 1 daily capsule of maltodextrin immediately after finishing their meal.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline interleukin 6 (IL-6)
Time Frame: 0 and 12 weeks
0 and 12 weeks
Change from baseline interleukin 1β (IL1β)
Time Frame: 0 and 12 weeks
0 and 12 weeks
Change from baseline interleukin 10 (IL10)
Time Frame: 0 and 12 weeks
0 and 12 weeks
Change from baseline cytokine Tumor necrosis factor (TNFα)
Time Frame: 0 and 12 weeks
0 and 12 weeks
Change from baseline Mcp1 (Monocyte Chemoattractant Protein-1)
Time Frame: 0 and 12 weeks
0 and 12 weeks
Transforming growth factor beta 1 (TGF-β1)
Time Frame: 0 and 12 weeks
0 and 12 weeks
Change from baseline Interferon gamma (INF-γ)
Time Frame: 0 and 12 weeks
0 and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline cluster of differentiation 4 "CD4+T cells"
Time Frame: 0 and 12 weeks
0 and 12 weeks
Change from baseline T lymphocytes
Time Frame: 0 and 12 weeks
0 and 12 weeks
Change from baseline cluster of differentiation 8 "CD8+ T cells"
Time Frame: 0 and 12 weeks
0 and 12 weeks
Change from baseline natural killer cells
Time Frame: 0 and 12 weeks
0 and 12 weeks
Change from baseline B lymphocytes
Time Frame: 0 and 12 weeks
0 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Investigación Hospital Universitario La Paz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Creaciones Aromáticas Industriales S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Lactobacillus plantarum 3547

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