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Completed

NCT Number: NCT06747143

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

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.

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Key information

Conditions

Immune Modulation

Age range

19 year–46 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus casei DN-114001

Dietary Supplement

Probiotic

Other names: Actimel

Primary outcomes

  1. 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

  2. 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,

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Collaborators

  • Danone Global Research & Innovation Center

Registry information

Official study title

"Study of Immunological Biomarkers in Response to Probiotic Intake"

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 24, 2024
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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