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

NCT ID: NCT06747143

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-01

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Immune Modulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Sequential intervention
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention group

Healthy subjects

Group Type EXPERIMENTAL

Lactobacillus casei DN-114001

Intervention Type DIETARY_SUPPLEMENT

Probiotic

Interventions

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Lactobacillus casei DN-114001

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Actimel

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

46 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role collaborator

University of Valladolid

OTHER

Sponsor Role lead

Responsible Party

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Alfredo Corell

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PROBIOINMUNE2003

Identifier Type: -

Identifier Source: org_study_id

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