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

NCT06313346 | Completed

• 1 other identifier: 2023.200
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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:

• Experimental group (n=30): daily consumption of one probiotic capsule.
• Placebo group (n=30): daily consumption of one placebo capsule.

Conditions

Probiotic; Microbiota

Keywords

Microbiota; Probiotic; Inflammation; Immune system; Humans; Randomized controlled trial; Cortisol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Salivary cortisol

  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

  Clinical Investigation Day 1 and Clinical Investigation Day 2

• Height

  Clinical Investigation Day 1.

• Body mass index

  Clinical Investigation Day 1 and Clinical Investigation Day 2.

• Body fat percentage

  Clinical Investigation Day 1 and Clinical Investigation Day 2.

Study Arms (2)

Probiotic group

EXPERIMENTAL

Subjects will consume one capsule of probiotic, daily, during 6 weeks.

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

Subjects will consume one capsule of placebo, daily, during 6 weeks.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic capsules

Probiotic group

Placebo DIETARY_SUPPLEMENT

Placebo capsules

Placebo group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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, 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Centre for Nutrition Research

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Inflammation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Fermín Milagro Yoldi, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

• Idoia Ibero-Baraibar, PhD

  University of Navarra

  STUDY CHAIR

• Carlos González-Navarro

  University of Navarra

  STUDY CHAIR

• Santiago Navas-Carretero

  University of Navarra

  STUDY CHAIR

• Roncesvalles Garayoa, PhD

  University of Navarra

  STUDY CHAIR

• Gabriela Arias

  University of Navarra

  STUDY CHAIR

• Blanca Martinez

  University of Navarra

  STUDY CHAIR

• Salomé Pérez

  University of Navarra

  STUDY CHAIR

• María Goñi

  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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double blinded, parallel intervention

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 15, 2024
• Study Start: January 8, 2024
• Primary Completion: April 24, 2024
• Study Completion: June 15, 2024
• Last Updated: November 19, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)