Clinical trial NCT06248177: Probiotic Effect on Gastrointestinal Symptoms (FLORABIOTIC REFUERZO).
Official title: Effect of a Probiotic Consumption on Gastrointestinal Symptoms in Adults Men and Women (FLORABIOTIC REFUERZO).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Probiotic
Gastrointestinal Symptoms
Microbiota
Keywords: Microbiota
Gastrointestinal symptoms
Probiotic
Humans
Crossover
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, double blinded, crossover intervention
Primary purpose: TREATMENT

Brief 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.

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 4 visits distributed in two phases of 6 weeks separated by 4 weeks of wash-out period. At the beginning and at the end of each phase there will be a clinical visit. In all visits anthropometric and body composition measurements, stool and saliva samples, as well as data about dietary and physical activity will be collected.

Eligibility criteria: Inclusion Criteria:

* Volunteers of both sexes aged between 18 and 65 years old.
* Volunteers with a body mass index between 18.5 and 30 kg/m2.
* Present some type of discomfort/discomfort at gastrointestinal levels without having a specific diagnosis.The gastrointestinal symptoms rating scale will be used to more objectively detect these symptoms. A score between 3 and 5 in any of the symptoms will be an inclusion criterion.
* 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 must 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 with medication, helicobacter pylori, celiac disease and other diagnosed intolerances, 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 with 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/day (women) and 20 units/day (men).
* Pregnant or breastfeeding women.
* Subjects who present some type of cognitive and/or psychological impediment.
* Subjects in whom poor collaboration is expected or with difficulties in 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: other probiotics).
* Subjects who are immersed in a significant lifestyle change.

Primary outcomes:
measure: Fecal microbiota
timeFrame: Clinical Investigation Days 1, 2, 3 and 4.
Secondary outcomes:
measure: Salivary cortisol
timeFrame: Clinical Investigation Days 1, 2, 3 and 4 (at wake up in the morning, and at the same time in each Clinical investigation days).
measure: Body weight
timeFrame: Clinical Investigation Days 1, 2, 3 and 4
measure: Height
timeFrame: Clinical Investigation Day 1
measure: Body mass index
timeFrame: Clinical Investigation Days 1, 2, 3 and 4
measure: Body fat percentage
timeFrame: Clinical Investigation Days 1, 2, 3 and 4
measure: Body muscle mass
timeFrame: Clinical Investigation Days 1, 2, 3 and 4
measure: Body lean mass
timeFrame: Clinical Investigation Days 1, 2, 3 and 4
measure: Body water mass
timeFrame: Clinical Investigation Days 1, 2, 3 and 4
measure: Body bone mass
timeFrame: Clinical Investigation Days 1, 2, 3 and 4
measure: Gastrointestinal symptoms
timeFrame: Clinical Investigation Days 1, 2, 3 and 4
measure: Dietary intake
timeFrame: Clinical Investigation Days 1, 2, 3 and 4
measure: Physical activity
timeFrame: Clinical Investigation Days 1, 2, 3 and 4
measure: Adherence to capsule consumption
timeFrame: Clinical Investigation Days 1, 2, 3 and 4
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Centre for Nutrition Research
state: Navarre
Study officials:
affiliation: University of Navarra
name: Fermín I 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, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Santiago Navas-Carretero, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: Gabriela Arias
role: STUDY_CHAIR
affiliation: University of Navarra
name: Roncesvalles Garayoa, PhD
role: STUDY_CHAIR
affiliation: University of Navarra
name: María Goñi
role: STUDY_CHAIR
affiliation: University of Navarra
name: Salomé Pérez
role: STUDY_CHAIR
References: