Probiotic Effect on Gastrointestinal Symptoms (FLORABIOTIC REFUERZO). (FLORABIOTIC)

Effect of a Probiotic Consumption on Gastrointestinal Symptoms in Adults Men and Women (FLORABIOTIC REFUERZO).

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.

Study Overview

• Status: Recruiting
• Conditions: Microbiota; Gastrointestinal Symptoms; 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Idoia Ibero-Baraibar, PhD; Phone Number: 806699 +34948425600; Email: iibero@unav.es
• Study Contact Backup: Name: Fermín Milagro Yoldi; Phone Number: 806553 +34948425600; Email: fmilagro@unav.es

Study Locations

• Spain
  • Navarre
    • Pamplona, Navarre, Spain
      • Recruiting
      • Centre for Nutrition Research
      • Contact: Fermin I Milagro, PhD; Phone Number: 806553 948425600; Email: fmilagro@unav.es

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 6 weeks daily consumption of one probiotic capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one placebo capsule	Dietary supplement: Placebo; Placebo capsules; Dietary supplement: Probiotic; Probiotic capsules
Active Comparator: Group 2; 6 weeks daily consumption of one placebo capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one probiotic capsule	Dietary supplement: Placebo; Placebo capsules; Dietary supplement: Probiotic; Probiotic 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 Days 1, 2, 3 and 4.

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 Days 1, 2, 3 and 4 (at wake up in the morning, and at the same time in each Clinical investigation days).
Body weight	Weight of participants will be measured by bioimpedance and reported in kg	Clinical Investigation Days 1, 2, 3 and 4
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 (kg)/ height (cm)2.	Clinical Investigation Days 1, 2, 3 and 4
Body fat percentage	Body fat of participants will be analyzed by bioimpedance and reported in percentage and kilograms.	Clinical Investigation Days 1, 2, 3 and 4
Body muscle mass	Body muscle mass of participants will be analyzed by bioimpedance and reported in kilograms.	Clinical Investigation Days 1, 2, 3 and 4
Body lean mass	Body lean mass of participants will be analyzed by bioimpedance and reported in kilograms.	Clinical Investigation Days 1, 2, 3 and 4
Body water mass	Body water mass of participants will be analyzed by bioimpedance and reported in kilograms.	Clinical Investigation Days 1, 2, 3 and 4
Body bone mass	Body bone mass of participants will be analyzed by bioimpedance and reported in kilograms.	Clinical Investigation Days 1, 2, 3 and 4
Gastrointestinal symptoms	Gastrointestinal symptoms will be registrated through 15 items likert questionnaire; gastrointestinal symptoms rating scale questionnaire.	Clinical Investigation Days 1, 2, 3 and 4
Dietary intake	Dietary intake will be analysed by food frequency questionnaire.	Clinical Investigation Days 1, 2, 3 and 4
Physical activity	Physical activity will be evaluated by the reduced version of the International Physical Activity Questionnaire (IPAQ).	Clinical Investigation Days 1, 2, 3 and 4
Adherence to capsule consumption	Adherence will be assessed using the capsule consumption record form.	Clinical Investigation Days 1, 2, 3 and 4

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Investigators: Study Chair: Salomé Pérez, University of Navarra; Principal Investigator: Fermín I Milagro Yoldi, PhD, University of Navarra; Study Chair: Idoia Ibero-Baraibar, PhD, University of Navarra; Study Chair: Carlos González-Navarro, PhD, University of Navarra; Study Chair: Santiago Navas-Carretero, 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 record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Humans; Microbiota; Crossover; Probiotic; Gastrointestinal symptoms
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Signs and Symptoms, Digestive
• Other Study ID Numbers: FLORABIOTIC REFUERZO

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