Adverse EffectsPROBIONCT07165457
Effect of Probiotic Intake in Healthy Population
A study testing Probiotic group in people with Adverse Effects and Healthy, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Effects, Healthy
- What is being tested?
- Probiotic group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 4 Sep 2025to 7 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Center for Nutrition Research
Pamplona, Navarre, 31008
Paula Aranaz, PhD, 948425600 ext. 806390, paranaz@unav.es
About this study
Official title: Clinical Evaluation of a Probiotic in Healthy Population (PROBIO)
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.
Read more
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).
Read the 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 visit to address any questions. Volunteers who agree to participate will sign the informed consent form.
During the intervention, participants will attend two clinical investigation visits. The first Clinical Investigation Day will be conducted on the same day as the screening, and the second Clinical Investigation Day will take place at the end of the 15-day period. In both visits, anthropometric measurements, gastrointestinal symptoms and a general questionnaire on adverse effects will be recorded. Volunteers will be required to consume one probiotic capsule per day during 15 days.
- Conditions
- Adverse Effects, Healthy
- Being tested
- Probiotic group
- Keywords
- Probiotic, Supplement, Microbiota, Gastrointestinal tract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic groupDietary supplement
Daily consumption of one capsule containing a probiotic for 15 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Capsule containing probiotic Receives: Dietary Supplement: Probiotic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Secondary outcomes (15)
Body weight
Weight of participants will be measured by bioimpedance and reported in kg
Measured: Clinical Investigation Day 1
Height
Height of participants will be measured by stadiometer and reported in m.
Measured: Clinical Investigation Day 1
Body mass index
Body mass index will be calculated as follows: weight (kilograms)/ height (cm)2
Measured: Clinical Investigation Day 1
Adherence to capsule consumption
Adherence will be assessed using the capsule consumption record form.
Measured: Clinical Investigation Day 2
Headache
Headache will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Tiredness
Tiredness will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Muscle or joint pain
Muscle or joint pain will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Fever
Fever will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Chills
Chills will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Allergic reactions
Allergic reactions will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Difficulty sleeping
Difficulty sleeping will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Dizziness
Dizziness will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
General discomfort
General discomfort will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Mood
Mood will be assess answering the General Questionnaire designed for the study. Answers could be No / Yes, mild / Yes, moderate / Yes, severe
Measured: Clinical Investigation Day 2
Other symptoms
Open question
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start4 Sep 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion7 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Idoia Ibero, PhD, Study chair, Center for Nutrition ResearchSalomé Pérez, Study chair, Center for Nutrition ResearchPaula Aranaz, PhD, Principal investigator, Center for Nutrition ResearchVerónica Ciaurriz, Study chair, Center for Nutrition ResearchAna Lorente, Study chair, Center for Nutrition Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165457
- Sponsor's protocol ID
- PROBIO (2025.158)
- Acronym
- PROBIO
- Status last verified
- Sep 2025
- First submitted
- 12 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Probiotic in Healthy Population (PROBIO)
- ClinicalTrials.gov ID
- NCT07165457
- Acronym / sponsor ID
- PROBIO / PROBIO (2025.158)
- Conditions
- Adverse Effects, Healthy
- Keywords
- Probiotic, Supplement, Microbiota, Gastrointestinal tract
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 4 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 7 Oct 2025 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 visit to address any questions. Volunteers who agree to participate will sign the informed consent form.
During the intervention, participants will attend two clinical investigation visits. The first Clinical Investigation Day will be conducted on the same day as the screening, and the second Clinical Investigation Day will take place at the end of the 15-day period. In both visits, anthropometric measurements, gastrointestinal symptoms and a general questionnaire on adverse effects will be recorded. Volunteers will be required to consume one probiotic capsule per day during 15 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic groupCapsule containing probiotic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic groupDaily consumption of one capsule containing a probiotic for 15 days | Dietary supplement | Probiotic group |
Primary outcome
Gastrointestinal symptoms
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
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.
15 secondary outcomes
Body weight
Time frame: Clinical Investigation Day 1
Height
Time frame: Clinical Investigation Day 1
Body mass index
Time frame: Clinical Investigation Day 1
Adherence to capsule consumption
Time frame: Clinical Investigation Day 2
Headache
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Tiredness
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Muscle or joint pain
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Fever
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Chills
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Allergic reactions
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Difficulty sleeping
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Dizziness
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
General discomfort
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Mood
Time frame: Clinical Investigation Day 2
Other symptoms
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Idoia Ibero, PhD study chair
Center for Nutrition Research
Salomé Pérez study chair
Center for Nutrition Research
Paula Aranaz, PhD principal investigator
Center for Nutrition Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic group in people with Adverse Effects and Healthy, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paula Aranaz, PhD (+34948425600 ext. 806390, paranaz@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal symptoms (time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.