Effect of Probiotic Intake in Healthy Population

NCT07165457 | Not Yet Recruiting

• 1 other identifier: PROBIO (2025.158)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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

Keywords

Probiotic; Supplement; Microbiota; Gastrointestinal tract

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal symptoms

  Gastrointestinal symptoms will be registrated through Gastrointestinal Symptoms Rating Scale questionnaire, which is a questionnaire of 15 items. The questionnaire has a seven-point graded likert-type scale, where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.

  Clinical Investigation Day 1 and Clinical Investigation Day 2

Secondary Outcomes (15)

• Body weight

  Clinical Investigation Day 1

• Height

  Clinical Investigation Day 1

• Body mass index

  Clinical Investigation Day 1

• Adherence to capsule consumption

  Clinical Investigation Day 2

• Headache

  Clinical Investigation Day 1 and Clinical Investigation Day 2

Study Arms (1)

Probiotic group

EXPERIMENTAL

Capsule containing probiotic

Dietary Supplement: Probiotic group

Interventions

Probiotic group DIETARY_SUPPLEMENT

Daily consumption of one capsule containing a probiotic for 15 days

Probiotic group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Center for Nutrition Research

Pamplona, Navarre, 31008, Spain

Location

Study Officials

• Idoia Ibero, PhD

  Center for Nutrition Research

  STUDY CHAIR

• Salomé Pérez

  Center for Nutrition Research

  STUDY CHAIR

• Paula Aranaz, PhD

  Center for Nutrition Research

  PRINCIPAL INVESTIGATOR

• Verónica Ciaurriz

  Center for Nutrition Research

  STUDY CHAIR

• Ana Lorente

  Center for Nutrition Research

  STUDY CHAIR

Central Study Contacts

Paula Aranaz, PhD

CONTACT

+34948425600; paranaz@unav.es

Fermín Milagro, PhD

CONTACT

+34948425600; fmilagro@unav.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 10, 2025
• Study Start: September 4, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 7, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)