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

University of Valladolid (UVA)

Status: Completed

Conditions: Immune Modulation

Treatments: Dietary Supplement: Lactobacillus casei DN-114001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06747143

PROBIOINMUNE2003

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 19 to 46 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Intervention group

Experimental group

Description:

Healthy subjects

Treatment:

Dietary Supplement: Lactobacillus casei DN-114001