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

Effect of a Probiotic Consumption on Microbiota Associated with the Immune System and Inflammation in Adult Women and Men (FLORABIOTIC INMUNITARIO).

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.

Study Overview

• Status: Completed
• Conditions: Microbiota; Probiotic
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

Detailed Description

Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly allocated to one of the two arms of the study and will be provided with any required material.

During the intervention, volunteers will attend two Clinical investigation visits. The first one will be carried out on the first day of the study and the last one will take place at the end of the 6 weeks. In both visits anthropometric and body composition measurements, stool and saliva samples, as well as data about dietary, physical activity and catarrhal episodes will be taken.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Centre for Nutrition Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Volunteers of both sexes.
• Age between 40 and 65 years old.
• Volunteers with a body mass index between 18.5 and 30 kg/m2.
• Subjects have to present a stable weight (+/- 3 kg) in the last three months prior to the start of the study.
• Subjects must be able to understand and be willing to sign the informed consent, and comply with all study procedures and requirements.

Exclusion Criteria:

• Subjects with relevant functional or structural anomalies of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux, etc.
• Subjects with surgical interventions with permanent consequences in the digestive system (for example, gastroduodenostomy).
• Subjects following treatments that alter gastrointestinal function, either chronically or occasionally.
• Subjects who are being treated with antibiotics (in order to participate, they do not have to have taken antibiotics during the two months prior to the baseline visit).
• Subjects with any type of cancer or undergoing treatment for it, or less than 5 years since its eradication.
• Subjects with any liver disease (may participate with non-alcoholic fatty liver disease).
• Subjects with allergy to any component of the product under study.
• Subjects with a high alcohol intake, more than 14 units (women)/day and 20 units (men)/day.
• Women who are breastfeeding or pregnant.
• Subjects who present some type of cognitive and/or psychological impairment.
• Subjects with poor collaboration or with difficulties for following the study procedures.
• Subjects who work with shift changes that include nights.
• Subjects who follow any type of supplementation that interferes with the study (example: consumption of probiotics).
• Subjects who are immersed in diet/exercise changes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; Subjects will consume one capsule of probiotic, daily, during 6 weeks.	Dietary supplement: Probiotic; Probiotic capsules
Placebo Comparator: Placebo group; Subjects will consume one capsule of placebo, daily, during 6 weeks.	Dietary supplement: Placebo; Placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal microbiota	Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.	Clinical Investigation Day 1 and Clinical Investigation Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary cortisol	Cortisol levels will be taken by Salivette®- Cortisol kit and analyzed by electrochemiluminescence immunoassay and reported in ug/dL.	Clinical Investigation Day 1 (at wake up in the morning) and Clinical Investigation Day 2 (at wake up in the morning, at the same time taken in the clinical investigation day 1)]
Body weight	Weight of participants will be measured by bioimpedance and reported in kg	Clinical Investigation Day 1 and Clinical Investigation Day 2
Height	Height of participants will be measured by stadiometer and reported in m.	Clinical Investigation Day 1.
Body mass index	Body mass index will be calculated as follows: weight (kilograms)/ height (cm)2.	Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body fat percentage	Body fat of participants will be analyzed by bioimpedance and reported in percentage and kilograms.	Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body muscle mass	Body muscle mass of participants will be analyzed by bioimpedance and reported in kilograms.	Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body lean mass	Body leen mass of participants will be analyzed by bioimpedance and reported in kilograms.	Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body water mass	Body water mass of participants will be analyzed by bioimpedance and reported in kilograms.	Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body bone mass	Body bone mass of participants will be analyzed by bioimpedance and reported in kilograms.	Clinical Investigation Day 1 and Clinical Investigation Day 2.
The incidence of catarrhal episodes	The number of catarrhal episodes will be registrated through a questionnaire designed for that purpose.	Clinical Investigation Day 1 and Clinical Investigation Day 2.
The gravity of catarrhal episodes	The gravity (mild/half /serious) of catarrhal episodes will be registrated through a questionnaire designed for that purpose.	Clinical Investigation Day 1 and Clinical Investigation Day 2.
Gastrointestinal symptoms	Gastrointestinal symptoms will be registrated through Gastrointestinal Symptoms Rating Scale questionnaire, which is a questionnaire of 15 items. The questionnaire has a seven-point graded likert-type scale, where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.	Clinical Investigation Day 1 and Clinical Investigation Day 2.
Dietary intake	Dietary intake (energy, macronutrients and micronutrients) will be analysed by food frequency questionnaire.	Clinical Investigation Day 1 and Clinical Investigation Day 2.
Physical activity	Physical activity will be evaluated by the reduced version of the International Physical Activity Questionnaire, which estimates the total physical activity in MET-min/week, time spent sitting and classifies subjects based on their physical activity	Clinical Investigation Day 1 and Clinical Investigation Day 2.
Adherence to capsule consumption	Adherence will be assessed using the capsule consumption record form.	Clinical Investigation Day 1 and Clinical Investigation Day 2.

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Investigators: Study Chair: Salomé Pérez, University of Navarra; Principal Investigator: Fermín Milagro Yoldi, PhD, University of Navarra; Study Chair: Idoia Ibero-Baraibar, PhD, University of Navarra; Study Chair: Gabriela Arias, University of Navarra; Study Chair: Roncesvalles Garayoa, PhD, University of Navarra; Study Chair: María Goñi, University of Navarra; Study Chair: Carlos González-Navarro, University of Navarra; Study Chair: Santiago Navas-Carretero, University of Navarra; Study Chair: Blanca Martinez, University of Navarra

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Actual): April 24, 2024
• Study Completion (Actual): June 15, 2024

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Inflammation; Humans; Randomized controlled trial; Microbiota; Cortisol; Probiotic; Immune system
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 2023.200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No