ProbioticFLORABIOTICNCT06248177
Probiotic Effect on Gastrointestinal Symptoms (FLORABIOTIC REFUERZO).
A study testing Probiotic in people with Probiotic and Gastrointestinal Symptoms, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
The goal of this randomized clinical trial is to evaluate the effect on the microbiota and the reduction in the number and/or intensity of symptoms of gastrointestinal discomfort of consuming a probiotic or placebo for 6 weeks in adult women and men. The main questions to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Probiotic, Gastrointestinal Symptoms, Microbiota
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jan 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers of both sexes aged between 18 and 65 years old.
- Volunteers with a body mass index between 18.5 and 30 kg/m2.
- Present some type of discomfort/discomfort at gastrointestinal levels without having a specific diagnosis.The gastrointestinal symptoms rating scale will be used to more objectively detect these symptoms. A score between 3 and 5 in any of the symptoms will be an inclusion criterion.
- Present a stable weight (+/- 3 kg) in the last three months prior to the start of the study.
- Subjects must be able to understand and be willing to sign the informed consent, and must comply with all study procedures and requirements.
Who cannot join
- Subjects with relevant functional or structural anomalies of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux with medication, helicobacter pylori, celiac disease and other diagnosed intolerances, etc.
- Subjects with surgical interventions with permanent consequences in the digestive system (for example, gastroduodenostomy).
- Subjects following treatments that alter gastrointestinal function, either chronically or occasionally.
- Subjects who are being treated with antibiotics (in order to participate, they do not have to have taken antibiotics during the two months prior to the baseline visit).
- Subjects with any type of cancer or undergoing treatment for it, or with less than 5 years since its eradication.
- Subjects with any liver disease (may participate with non-alcoholic fatty liver disease).
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- Subjects with allergy to any component of the product under study.
- Subjects with a high alcohol intake, more than 14 units/day (women) and 20 units/day (men).
- Pregnant or breastfeeding women.
- Subjects who present some type of cognitive and/or psychological impediment.
- Subjects in whom poor collaboration is expected or with difficulties in following the study procedures.
- Subjects who work with shift changes that include nights.
- Subjects who follow any type of supplementation that interferes with the study (example: other probiotics).
- Subjects who are immersed in a significant lifestyle change.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Probiotic Consumption on Gastrointestinal Symptoms in Adults Men and Women (FLORABIOTIC REFUERZO).
The goal of this randomized clinical trial is to evaluate the effect on the microbiota and the reduction in the number and/or intensity of symptoms of gastrointestinal discomfort of consuming a probiotic or placebo for 6 weeks in adult women and men.
The main questions to answer are:
Read more
- To study changes in the alpha diversity of the microbiota.
- To evaluate changes in the salivary cortisol.
For this purpose, a randomized, double blind crossover study has been designed.
Target sample size is 30 subjects.
Participants will be allocated in two groups for 16 weeks (6 weeks consuming one of the products + 4 weeks wash-out period + 6 weeks consuming the other product).
- Group 1 (n=15): 6 weeks daily consumption of one probiotic capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one placebo capsule.
- Group 2 (n=15): 6 weeks daily consumption of one placebo capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one probiotic capsule.
Read the detailed description
Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly allocated to one of the two arms of the study and will be provided with any required material.
During the intervention, volunteers will attend 4 visits distributed in two phases of 6 weeks separated by 4 weeks of wash-out period. At the beginning and at the end of each phase there will be a clinical visit. In all visits anthropometric and body composition measurements, stool and saliva samples, as well as data about dietary and physical activity will be collected.
- Conditions
- Probiotic, Gastrointestinal Symptoms, Microbiota
- Being tested
- Probiotic, Placebo
- Keywords
- Microbiota, Gastrointestinal symptoms, Probiotic, Humans, Crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic capsules
PlaceboDietary supplement
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 6 weeks daily consumption of one probiotic capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one placebo capsule Receives: Dietary Supplement: Probiotic; Dietary Supplement: Placebo |
| Group 2 | Active comparator | 6 weeks daily consumption of one placebo capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one probiotic capsule Receives: Dietary Supplement: Probiotic; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiota
Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.
Measured: Clinical Investigation Days 1, 2, 3 and 4.
Secondary outcomes (13)
Salivary cortisol
Cortisol levels will be taken by Salivette®- Cortisol kit and analyzed by electrochemiluminescence immunoassay and reported in ug/dL.
Measured: Clinical Investigation Days 1, 2, 3 and 4 (at wake up in the morning, and at the same time in each Clinical investigation days).
Body weight
Weight of participants will be measured by bioimpedance and reported in kg
Measured: Clinical Investigation Days 1, 2, 3 and 4
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 (kg)/ height (cm)2.
Measured: Clinical Investigation Days 1, 2, 3 and 4
Body fat percentage
Body fat of participants will be analyzed by bioimpedance and reported in percentage and kilograms.
Measured: Clinical Investigation Days 1, 2, 3 and 4
Body muscle mass
Body muscle mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Days 1, 2, 3 and 4
Body lean mass
Body lean mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Days 1, 2, 3 and 4
Body water mass
Body water mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Days 1, 2, 3 and 4
Body bone mass
Body bone mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Days 1, 2, 3 and 4
Gastrointestinal symptoms
Gastrointestinal symptoms will be registrated through 15 items likert questionnaire; gastrointestinal symptoms rating scale questionnaire.
Measured: Clinical Investigation Days 1, 2, 3 and 4
Dietary intake
Dietary intake will be analysed by food frequency questionnaire.
Measured: Clinical Investigation Days 1, 2, 3 and 4
Physical activity
Physical activity will be evaluated by the reduced version of the International Physical Activity Questionnaire (IPAQ).
Measured: Clinical Investigation Days 1, 2, 3 and 4
Adherence to capsule consumption
Adherence will be assessed using the capsule consumption record form.
Measured: Clinical Investigation Days 1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start16 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, double blinded, crossover intervention
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fermín I Milagro Yoldi, PhD, Principal investigator, University of NavarraIdoia Ibero-Baraibar, PhD, Study chair, University of NavarraCarlos González-Navarro, PhD, Study chair, University of NavarraSantiago Navas-Carretero, PhD, Study chair, University of NavarraGabriela Arias, Study chair, University of NavarraRoncesvalles Garayoa, PhD, Study chair, University of NavarraMaría Goñi, Study chair, University of NavarraSalomé Pérez, Study chair, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248177
- Sponsor's protocol ID
- 2023.199
- Acronym
- FLORABIOTIC
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 19 Nov 2024
- 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 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Probiotic Consumption on Gastrointestinal Symptoms in Adults Men and Women (FLORABIOTIC REFUERZO).
- ClinicalTrials.gov ID
- NCT06248177
- Acronym / sponsor ID
- FLORABIOTIC / 2023.199
- Conditions
- Probiotic, Gastrointestinal Symptoms, Microbiota
- Keywords
- Microbiota, Gastrointestinal symptoms, Probiotic, Humans, Crossover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 8 Feb 2024 (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 goal of this randomized clinical trial is to evaluate the effect on the microbiota and the reduction in the number and/or intensity of symptoms of gastrointestinal discomfort of consuming a probiotic or placebo for 6 weeks in adult women and men.
The main questions to answer are:
- To study changes in the alpha diversity of the microbiota.
- To evaluate changes in the salivary cortisol.
For this purpose, a randomized, double blind crossover study has been designed.
Target sample size is 30 subjects.
Participants will be allocated in two groups for 16 weeks (6 weeks consuming one of the products + 4 weeks wash-out period + 6 weeks consuming the other product).
- Group 1 (n=15): 6 weeks daily consumption of one probiotic capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one placebo capsule.
- Group 2 (n=15): 6 weeks daily consumption of one placebo capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one probiotic capsule.
Detailed description
Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly allocated to one of the two arms of the study and will be provided with any required material.
During the intervention, volunteers will attend 4 visits distributed in two phases of 6 weeks separated by 4 weeks of wash-out period. At the beginning and at the end of each phase there will be a clinical visit. In all visits anthropometric and body composition measurements, stool and saliva samples, as well as data about dietary and physical activity will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double blinded, crossover intervention
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Dietary Supplement: Probiotic, Dietary Supplement: Placebo6 weeks daily consumption of one probiotic capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one placebo capsule |
| Group 2 | Active comparator | Dietary Supplement: Probiotic, Dietary Supplement: Placebo6 weeks daily consumption of one placebo capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one probiotic capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers of both sexes aged between 18 and 65 years old.
- Volunteers with a body mass index between 18.5 and 30 kg/m2.
- Present some type of discomfort/discomfort at gastrointestinal levels without having a specific diagnosis.The gastrointestinal symptoms rating scale will be used to more objectively detect these symptoms. A score between 3 and 5 in any of the symptoms will be an inclusion criterion.
- Present a stable weight (+/- 3 kg) in the last three months prior to the start of the study.
- Subjects must be able to understand and be willing to sign the informed consent, and must comply with all study procedures and requirements.
Key exclusion criteria (14 listed)
- Subjects with relevant functional or structural anomalies of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux with medication, helicobacter pylori, celiac disease and other diagnosed intolerances, etc.
- Subjects with surgical interventions with permanent consequences in the digestive system (for example, gastroduodenostomy).
- Subjects following treatments that alter gastrointestinal function, either chronically or occasionally.
- Subjects who are being treated with antibiotics (in order to participate, they do not have to have taken antibiotics during the two months prior to the baseline visit).
- Subjects with any type of cancer or undergoing treatment for it, or with less than 5 years since its eradication.
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 |
|---|---|---|
| ProbioticProbiotic capsules | Dietary supplement | Group 1, Group 2 |
| PlaceboPlacebo capsules | Dietary supplement | Group 1, Group 2 |
Primary outcome
Fecal microbiota
Time frame: Clinical Investigation Days 1, 2, 3 and 4.
Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.
13 secondary outcomes
Salivary cortisol
Time frame: Clinical Investigation Days 1, 2, 3 and 4 (at wake up in the morning, and at the same time in each Clinical investigation days).
Body weight
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Height
Time frame: Clinical Investigation Day 1
Body mass index
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Body fat percentage
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Body muscle mass
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Body lean mass
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Body water mass
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Body bone mass
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Gastrointestinal symptoms
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Dietary intake
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Physical activity
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Adherence to capsule consumption
Time frame: Clinical Investigation Days 1, 2, 3 and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- 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. This study is not recruiting at the moment.
Fermín I Milagro Yoldi, PhD principal investigator
University of Navarra
Idoia Ibero-Baraibar, PhD study chair
University of Navarra
Carlos González-Navarro, PhD study chair
University of Navarra
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 in people with Probiotic and Gastrointestinal Symptoms, 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 19 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microbiota (time frame: Clinical Investigation Days 1, 2, 3 and 4.). 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 19 Nov 2024.