ProbioticFLORABIOTICNCT06313346

Effect of a Probiotic on Microbiota Associated with the Immune System and Inflammation.

A study testing Probiotic in people with Probiotic and Microbiota, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this randomized clinical trial is to learn about the effect of consuming a probiotic on the microbiota associated with immune health and inflammation in healthy women and men after 6 weeks of intervention. The main questions to answer are: 1. Read more about this study

Who is it for?: Ages 40 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Probiotic, 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: 60 participants
Where: 1 siteSpain
Study dates: 8 Jan 2024to 15 Jun 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 40 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Volunteers of both sexes.
Age between 40 and 65 years old.
Volunteers with a body mass index between 18.5 and 30 kg/m2.
Subjects have to 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 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, 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 less than 5 years since its eradication.
Subjects with any liver disease (may participate with non-alcoholic fatty liver disease).

Show all 14Show fewer

Subjects with allergy to any component of the product under study.
Subjects with a high alcohol intake, more than 14 units (women)/day and 20 units (men)/day.
Women who are breastfeeding or pregnant.
Subjects who present some type of cognitive and/or psychological impairment.
Subjects with poor collaboration or with difficulties for 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: consumption of probiotics).
Subjects who are immersed in diet/exercise changes.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Centre for Nutrition Research
Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: Effect of a Probiotic Consumption on Microbiota Associated with the Immune System and Inflammation in Adult Women and Men (FLORABIOTIC INMUNITARIO).

The main questions to answer are:

To study changes in the intestinal microbiota associated with immune health and inflammation related to probiotic intake.
To evaluate changes in salivary cortisol after ingestion of the probiotic.
To compile the number and intensity of catarrhal episodes suffered by the participants along the study.

For this purpose, a randomized, double blind parallel study has been designed.

Target sample size is 60 subjects.

Participants will be allocated in two groups for 6 weeks:

Experimental group (n=30): daily consumption of one probiotic capsule.
Placebo group (n=30): daily consumption of one placebo 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 two Clinical investigation visits. The first one will be carried out on the first day of the study and the last one will take place at the end of the 6 weeks. In both visits anthropometric and body composition measurements, stool and saliva samples, as well as data about dietary, physical activity and catarrhal episodes will be taken.

Conditions: Probiotic, Microbiota
Being tested: Probiotic, Placebo
Keywords: Microbiota, Probiotic, Inflammation, Immune system, Humans, Randomized controlled trial, Cortisol
Medical subject headings: Inflammation

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 groups in NCT06313346
Study group	Role	What they receive
Probiotic group	Experimental	Subjects will consume one capsule of probiotic, daily, during 6 weeks. Receives: Dietary Supplement: Probiotic
Placebo group	Placebo comparator	Subjects will consume one capsule of placebo, daily, during 6 weeks. Receives: 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 Day 1 and Clinical Investigation Day 2

Secondary outcomes (15)

Salivary cortisol
Cortisol levels will be taken by Salivette®- Cortisol kit and analyzed by electrochemiluminescence immunoassay and reported in ug/dL.
Measured: Clinical Investigation Day 1 (at wake up in the morning) and Clinical Investigation Day 2 (at wake up in the morning, at the same time taken in the clinical investigation day 1)]
Body weight
Weight of participants will be measured by bioimpedance and reported in kg
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
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 and Clinical Investigation Day 2.
Body fat percentage
Body fat of participants will be analyzed by bioimpedance and reported in percentage and kilograms.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body muscle mass
Body muscle mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body lean mass
Body leen mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body water mass
Body water mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body bone mass
Body bone mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2.
The incidence of catarrhal episodes
The number of catarrhal episodes will be registrated through a questionnaire designed for that purpose.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2.
The gravity of catarrhal episodes
The gravity (mild/half /serious) of catarrhal episodes will be registrated through a questionnaire designed for that purpose.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2.
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.
Dietary intake
Dietary intake (energy, macronutrients and micronutrients) will be analysed by food frequency questionnaire.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Physical activity
Physical activity will be evaluated by the reduced version of the International Physical Activity Questionnaire, which estimates the total physical activity in MET-min/week, time spent sitting and classifies subjects based on their physical activity
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Adherence to capsule consumption
Adherence will be assessed using the capsule consumption record form.
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.

8 Jan 202415 Jun 2024

First posted15 Mar 2024
Study start8 Jan 2024
Primary completion24 Apr 2024
Study completion15 Jun 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomised, double blinded, parallel intervention
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06313346
Sponsor's protocol ID: 2023.200
Acronym: FLORABIOTIC
Status last verified: Dec 2023
First submitted: 1 Mar 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
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Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
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All Probiotic trials

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 Microbiota Associated with the Immune System and Inflammation in Adult Women and Men (FLORABIOTIC INMUNITARIO).
ClinicalTrials.gov ID: NCT06313346
Acronym / sponsor ID: FLORABIOTIC / 2023.200
Conditions: Probiotic, Microbiota
Keywords: Microbiota, Probiotic, Inflammation, Immune system, Humans, Randomized controlled trial, Cortisol
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
Study start: 8 Jan 2024 (actual)
Primary completion: 24 Apr 2024 (actual)
Study completion: 15 Jun 2024 (actual)
First posted: 15 Mar 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 main questions to answer are:

To study changes in the intestinal microbiota associated with immune health and inflammation related to probiotic intake.
To evaluate changes in salivary cortisol after ingestion of the probiotic.
To compile the number and intensity of catarrhal episodes suffered by the participants along the study.

For this purpose, a randomized, double blind parallel study has been designed.

Target sample size is 60 subjects.

Participants will be allocated in two groups for 6 weeks:

Experimental group (n=30): daily consumption of one probiotic capsule.
Placebo group (n=30): daily consumption of one placebo capsule.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomised, double blinded, parallel intervention

Arm	Type	Receives
Probiotic group	Experimental	Dietary Supplement: ProbioticSubjects will consume one capsule of probiotic, daily, during 6 weeks.
Placebo group	Placebo comparator	Dietary Supplement: PlaceboSubjects will consume one capsule of placebo, daily, during 6 weeks.

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Volunteers of both sexes.
Age between 40 and 65 years old.
Volunteers with a body mass index between 18.5 and 30 kg/m2.
Subjects have to 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 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, 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 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	Probiotic group
PlaceboPlacebo capsules	Dietary supplement	Placebo group

Primary outcome

Fecal microbiota
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.

15 secondary outcomes

Salivary cortisol
Time frame: Clinical Investigation Day 1 (at wake up in the morning) and Clinical Investigation Day 2 (at wake up in the morning, at the same time taken in the clinical investigation day 1)]
Body weight
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Height
Time frame: Clinical Investigation Day 1.
Body mass index
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body fat percentage
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body muscle mass
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body lean mass
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body water mass
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Body bone mass
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
The incidence of catarrhal episodes
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
The gravity of catarrhal episodes
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Gastrointestinal symptoms
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Dietary intake
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Physical activity
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.
Adherence to capsule consumption
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.

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

Related trials for Probiotic

Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
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Not yet recruiting
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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 Milagro Yoldi, PhD principal investigator

University of Navarra

Idoia Ibero-Baraibar, PhD study chair

University of Navarra

Carlos González-Navarro 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 Microbiota, 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. Some participants in this study may receive a placebo. 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 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?

On the ClinicalTrials.gov record for NCT06313346.

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.