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Effect of Probiotic Intake in Healthy Population

Study acronym: PROBIO
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated September 10, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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).
Trial Details
NCT Number NCT07165457
Lead Sponsor Clinica Universidad de Navarra, Universidad de Navarra
Conditions
(from sponsor)		 Adverse Effects, Healthy
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov