Short-term Immunomodulatory Effects of Lactobacillus Casei DN-114001: Impacts on Gut Microbiota Composition and Systemic Immune Biomarkers in Healthy Adults

January 3, 2025 updated by: Alfredo Corell, University of Valladolid

"Study of Immunological Biomarkers in Response to Probiotic Intake"

The study included 21 adult participants, aged 19-46 years (19 female participants and 2 male participants). The selection criteria included the following parameters: Body Mass Index (BMI), calculated as weight (kg) divided by height squared (m²), between 18.5 and 29.99; Waist-to-Hip Ratio with thresholds set at >0.90 for males and >0.85 for females for individuals with normal weight (eutrophic); percentage of body fat: Considered within normal range if <30% for individuals with normal weight. Standard biochemical and anthropometric measurements were carried out to all the subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Body Mass Index (BMI) between 18.5 and 29.99;
  • Waist-to-Hip Ratio with thresholds set at >0.90 for males and >0.85 for females for individuals with normal weight (eutrophic)
  • Percentage of body fat: Considered within normal range if <30% for individuals with normal weight.

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Healthy subjects
Dietary supplement: Lactobacillus casei DN-114001
Probiotic
Other Names:
  • Actimel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal flora cultures (Count of colonies/mL)
Time Frame: From enrollment to the end of treatment at 45 days weeks, every 15 days
Relative amount of colonies (CFU) of Escherichia coli, Clostridium species and Lactobacillus
From enrollment to the end of treatment at 45 days weeks, every 15 days
Serum immunoglobulins
Time Frame: From enrollment to the end of treatment at 45 days weeks, every 15 days
Serum concentration of G, A, M, and G subclasses, as well as the complement C3 and C4 factors,
From enrollment to the end of treatment at 45 days weeks, every 15 days
Lymphocyte Subpopulations
Time Frame: From enrollment to the end of treatment at 45 days weeks, every 15 days
Concentration of T Lymphocytes: CD3, CD4, CD8, CD45 RA, and CD45 RO (distinguishing between helper T cells, cytotoxic T cells, and naïve or memory subsets within each group). ii) B Lymphocytes: CD19; iii) NK Cells: CD16 and CD56.
From enrollment to the end of treatment at 45 days weeks, every 15 days

Collaborators and Investigators

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

Sponsor

University of Valladolid

Collaborators

Danone Global Research & Innovation Center

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

February 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

December 18, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROBIOINMUNE2003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not needed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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