Effect of a Probiotic on Microbiota Associated with the Immune System and Inflammation.

Summary

The goal of this randomized clinical trial is to learn about the effect of consuming a probiotic on the microbiota associated with immune health and inflammation in healthy women and men after 6 weeks of intervention.

The main questions to answer are:

1. To study changes in the intestinal microbiota associated with immune health and inflammation related to probiotic intake.
2. To evaluate changes in salivary cortisol after ingestion of the probiotic.
3. To compile the number and intensity of catarrhal episodes suffered by the participants along the study.

For this purpose, a randomized, double blind parallel study has been designed.

Target sample size is 60 subjects.

Participants will be allocated in two groups for 6 weeks:

* Experimental group (n=30): daily consumption of one probiotic capsule.
* Placebo group (n=30): daily consumption of one placebo capsule.

Conditions

• Probiotic
• Microbiota

Interventions

DIETARY_SUPPLEMENT

Probiotic

Probiotic capsules

DIETARY_SUPPLEMENT

Placebo

Placebo capsules

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Principal Investigators

• Fermín Milagro Yoldi, PhD · University of Navarra

• Idoia Ibero-Baraibar, PhD · University of Navarra

• Carlos González-Navarro · University of Navarra

• Santiago Navas-Carretero · University of Navarra

• Roncesvalles Garayoa, PhD · University of Navarra

• Gabriela Arias · University of Navarra

• Blanca Martinez · University of Navarra

• Salomé Pérez · University of Navarra

• María Goñi · University of Navarra

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-08

Primary Completion

2024-04-24

Completion

2024-06-15

Countries

• Spain

Study Locations