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

NCT06747143 | Completed

• 1 other identifier: PROBIOINMUNE2003
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Immune Modulation

Keywords

lactobacillus casei

Outcome Measures

Primary Outcomes (3)

• Fecal flora cultures (Count of colonies/mL)

  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

  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

  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

Study Arms (1)

Intervention group

EXPERIMENTAL

Healthy subjects

Dietary Supplement: Lactobacillus casei DN-114001

Interventions

Lactobacillus casei DN-114001 DIETARY_SUPPLEMENT

Probiotic

Also known as: Actimel

Intervention group

Eligibility Criteria

• Age: 19 Years - 46 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Valladolid: lead
• Danone Global Research & Innovation Center: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Sequential intervention

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share