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

Study of Immunological Biomarkers in Response to Probiotic Intake

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06747143

Enrollment

Registered

2024-12-24

Start date

2013-02-01

Completion date

2013-09-30

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Modulation

Keywords

lactobacillus casei

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus casei DN-114001

Probiotic

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Sequential intervention

Eligibility

Sex/Gender

ALL

Age

19 Years to 46 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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,
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
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026