Status:
NOT_YET_RECRUITING
Effect of Probiotic Intake in Healthy Population
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Adverse Effects
Healthy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 thi...
Detailed Description
Volunteers who wish to participate in the study will complete an online questionnaire to verify the main inclusion criteria. Those who meet the criteria will be invited to an information and screening...
Eligibility Criteria
Inclusion
- Healthy men and women aged between 18 and 70 years.
- Stable body weight (±5%) during the three months prior to study initiation.
- Physical examination and vital signs within normal limits or clinically irrelevant for the study.
- Subjects must be able to understand and willing to sign the informed consent form, and comply with all study procedures and requirements.
- Ongoing pharmacological/hormonal treatment will be permitted provided it does not affect the parameters under investigation and the dosage has been stable for at least three months prior to study initiation.
- Willingness to undergo all study procedures, including daily consumption of one probiotic capsule during the intervention.
- Availability in terms of time and location to attend the two scheduled in-person clinical evaluation sessions.
Exclusion
- Volunteers undergoing pharmacological treatment with unstable dosing (less than 3 months prior to study initiation) will be excluded, particularly if treatments:
- Affect gastrointestinal function.
- Include chronically prescribed stomach protectants.
- Subjects with significant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, chronic reflux, etc.
- Subjects who have undergone surgical procedures resulting in permanent alterations of the digestive system (e.g., gastroduodenostomy) or bariatric surgery.
- Presence of systemic intestinal, hepatic, or renal diseases, such as uncontrolled thyroid disorders, cirrhosis, inflammatory bowel disease, untreated anemia, etc. (non-alcoholic fatty liver disease will not be excluded).
- Alcohol consumption exceeding the sex-specific limits (\>14 units/week for women, \>20 units/week for men).
- Pregnancy, lactation, or plans to become pregnant during the study period.
- Use of nutritional supplements that may affect study outcomes (e.g., weight-loss supplements, newly initiated fiber supplements, probiotics, postbiotics, etc.).
- Subjects with any type of cancer currently undergoing treatment, or with less than five years since cancer remission.
- Known allergy to any component of the investigational product.
- Presence of cognitive and/or psychological impairments.
- Anticipated poor compliance or, in the investigator's opinion, difficulty adhering to study procedures.
- Participation in any weight loss or body composition modification treatments.
- Use of antibiotics within 15 days prior to the baseline visit.
Key Trial Info
Start Date :
September 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 7 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07165457
Start Date
September 4 2025
End Date
October 7 2025
Last Update
September 10 2025
Active Locations (1)
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1
Center for Nutrition Research
Pamplona, Navarre, Spain, 31008