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NOT YET RECRUITING
NCT07165457
NA

Effect of Probiotic Intake in Healthy Population

Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Probiotic group

Daily consumption of one capsule containing a probiotic for 15 days

Locations (1)

Center for Nutrition Research

Pamplona, Navarre, Spain