Probiotic Effect on Gastrointestinal Symptoms (FLORABIOTIC REFUERZO).

NCT06248177 | Completed

• 1 other identifier: 2023.199
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

Microbiota; Gastrointestinal symptoms; Probiotic; Humans; Crossover

Outcome Measures

Primary Outcomes (1)

• Fecal microbiota

  Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.

  Clinical Investigation Days 1, 2, 3 and 4.

Secondary Outcomes (13)

• Salivary cortisol

  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

  Clinical Investigation Days 1, 2, 3 and 4

• Height

  Clinical Investigation Day 1

• Body mass index

  Clinical Investigation Days 1, 2, 3 and 4

• Body fat percentage

  Clinical Investigation Days 1, 2, 3 and 4

Study Arms (2)

Group 1

ACTIVE COMPARATOR

6 weeks daily consumption of one probiotic capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one placebo capsule

Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Group 2

ACTIVE COMPARATOR

6 weeks daily consumption of one placebo capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one probiotic capsule

Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic capsules

Group 1; Group 2

Placebo DIETARY_SUPPLEMENT

Placebo capsules

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Centre for Nutrition Research

Pamplona, Navarre, Spain

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Fermín I Milagro Yoldi, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Salomé Pérez

  University of Navarra

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The products (experimental and placebo), will be produced by an external producer, who will save the codes. None of the researchers involved in the study development or analyses will know the association until the end of the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double blinded, crossover intervention

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: January 16, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)