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

Not Applicable

Completed

• Conditions: Immune Modulation

• Registration Number: NCT06747143
• Lead Sponsor: University of Valladolid

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-01
• Primary Completion: 2013-04
• Study Completion: 2013-09
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Fecal flora cultures (Count of colonies/mL)	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
Serum immunoglobulins	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,
Lymphocyte Subpopulations	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.