Clinical trial NCT06313346: Effect of a Probiotic on Microbiota Associated with the Immune System and Inflammation.
Official title: Effect of a Probiotic Consumption on Microbiota Associated with the Immune System and Inflammation in Adult Women and Men (FLORABIOTIC INMUNITARIO).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Probiotic
Microbiota
Keywords: Microbiota
Probiotic
Inflammation
Immune system
Humans
Randomized controlled trial
Cortisol
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, double blinded, parallel intervention
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fecal microbiota
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Secondary outcomes:
measure: Salivary cortisol
timeFrame: 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)]
measure: Body weight
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2
measure: Height
timeFrame: Clinical Investigation Day 1.
measure: Body mass index
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
measure: Body fat percentage
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
measure: Body muscle mass
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
measure: Body lean mass
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
measure: Body water mass
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
measure: Body bone mass
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
measure: The incidence of catarrhal episodes
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
measure: The gravity of catarrhal episodes
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
measure: Gastrointestinal symptoms
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
measure: Dietary intake
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
measure: Physical activity
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
measure: Adherence to capsule consumption
timeFrame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Centre for Nutrition Research
state: Navarre
Study officials:
affiliation: University of Navarra
name: Fermín Milagro Yoldi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Navarra
name: Idoia Ibero-Baraibar, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Carlos González-Navarro
role: STUDY_CHAIR
affiliation: University of Navarra
name: Santiago Navas-Carretero
role: STUDY_CHAIR
affiliation: University of Navarra
name: Roncesvalles Garayoa, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Gabriela Arias
role: STUDY_CHAIR
affiliation: University of Navarra
name: Blanca Martinez
role: STUDY_CHAIR
affiliation: University of Navarra
name: Salomé Pérez
role: STUDY_CHAIR
affiliation: University of Navarra
name: María Goñi
role: STUDY_CHAIR
References: