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Effect of Probiotic Intake in Healthy Population
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
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).
Official title: Clinical Evaluation of a Probiotic in Healthy Population (PROBIO)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-09-04
Completion Date
2025-10-07
Last Updated
2025-09-10
Healthy Volunteers
Yes
Conditions
Interventions
Probiotic group
Daily consumption of one capsule containing a probiotic for 15 days
Locations (1)
Center for Nutrition Research
Pamplona, Navarre, Spain