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Effect of Probiotic Intake in Healthy Population

NCT07165457 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-10

No results posted yet for this study

Summary

The main objective of this project is to evaluate the absence of adverse gastrointestinal effects following the consumption of a daily probiotic capsule during 15 days.

The secondary objective of this study is to verify the absence of any adverse effects other than gastrointestinal ones following the daily consumption of a probiotic during 15 days in a healthy population.

Specific objectives are:

* To evaluate changes in gastrointestinal health through self-reported questionnaire.
* To determine the adherence to probiotic consumption.
* To analyse headache, tiredness/fatigue, muscle or joint pain, fever or low-grade fever, chills, allergic reactions, difficulty sleeping, dizziness and general discomfort by General Adverse Effects Questionnaire.

Target sample size is 20 subjects.

Participants will be allocated in one group (experimental group).

Participants will visit nutritional intervention unit at Clinical Investigation Day 1 (day 1) and at Clinical Investigation Day 2 (day 15).

Conditions

  • Adverse Effects
  • Healthy

Interventions

DIETARY_SUPPLEMENT

Probiotic group

Daily consumption of one capsule containing a probiotic for 15 days

Sponsors & Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Principal Investigators

  • Idoia Ibero, PhD · Center for Nutrition Research

  • Salomé Pérez · Center for Nutrition Research

  • Paula Aranaz, PhD · Center for Nutrition Research

  • Verónica Ciaurriz · Center for Nutrition Research

  • Ana Lorente · Center for Nutrition Research

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2025-09-30
Completion
2025-10-07

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07165457 on ClinicalTrials.gov