Probiotic Effect on Gastrointestinal Symptoms (FLORABIOTIC REFUERZO).

Summary

The goal of this randomized clinical trial is to evaluate the effect on the microbiota and the reduction in the number and/or intensity of symptoms of gastrointestinal discomfort of consuming a probiotic or placebo for 6 weeks in adult women and men.

The main questions to answer are:

1. To study changes in the alpha diversity of the microbiota.
2. To evaluate changes in the salivary cortisol.

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

Target sample size is 30 subjects.

Participants will be allocated in two groups for 16 weeks (6 weeks consuming one of the products + 4 weeks wash-out period + 6 weeks consuming the other product).

* Group 1 (n=15): 6 weeks daily consumption of one probiotic capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one placebo capsule.
* Group 2 (n=15): 6 weeks daily consumption of one placebo capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one probiotic capsule.

Conditions

• Probiotic
• Gastrointestinal Symptoms
• 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 I Milagro Yoldi, PhD · University of Navarra

• Idoia Ibero-Baraibar, PhD · University of Navarra

• Carlos González-Navarro, PhD · University of Navarra

• Santiago Navas-Carretero, PhD · University of Navarra

• Gabriela Arias · University of Navarra

• Roncesvalles Garayoa, PhD · University of Navarra

• María Goñi · University of Navarra

• Salomé Pérez · University of Navarra

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-16

Primary Completion

2024-06-30

Completion

2024-07-30

Countries

• Spain

Study Locations