FrailtyFRAGBIOTANCT07251322
Relationship Between Frailty and Gut Microbiota in Older Adults: An Educational Program for Healthy Aging
An observational study of Frailty and Microbiota, run by University of Cadiz at 1 site in Spain.
Trial summary
The main objective of this pre-experimental study is to describe the relationship between gut microbiota and changes in the degree of frailty in older adults who participated in an educational program. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Microbiota
- What is being tested?
- Fecal sample collection
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 25 Aug 2025to 24 Sep 2025
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: A cohort of participants of the FRAGSALUD project (older adults with at least one Fried's frailty criterion), that will be divided into to responders (if they reduced their levels of frailty) and non-responders (if they did not reduced their levels of frailty) after the FRAGSALUD intervention (an educactional program of four sessions and six telephone calls)
Who may be able to join
- Patients over 65 years of age who present frailty or pre-frailty, assessed using the Fried criteria adapted to the Spanish population
- Patients belonging to the Clinical Management Units participating in the study and who will remain in them for the 12 months of the study
- Patients who are able to attend the Health Center alone or accompanied
Who cannot join
- COPD stage III or IV, unstable angina, uncontrolled congestive heart failure, or unstable arrhythmia
- Patients who cannot walk independently or with assistive devices, such as bedridden individuals
- Patients in nursing homes
- Patients with severe cognitive impairment
- Patients who do not understand Spanish or English
- Patients with allergies to plastic or metal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Frailty and Gut Microbiota in Older Adults: Relevance for a Healthy Aging Education Program
The main objective of this pre-experimental study is to describe the relationship between gut microbiota and changes in the degree of frailty in older adults who participated in an educational program. More specifically, the study aims to: determine the gut microbiota profile of community-dwelling older adults, both robust and frail; analyze the effect of a 12-month educational program on gut microbiota; examine the association of gut microbiota with physical function, functional dependency, and physical activity in frail or pre-frail older adults who received the program; investigate its relationship with the risk of malnutrition; relate the gut microbiota profile to quality of life, depressive symptoms, and social support; and, finally, associate gut microbiota with cognitive frailty and sleep quality in this group of older adults who participated in the health promotion educational intervention.
Read the detailed description
This non-randomized pre-experimental study was conducted in the province of Cádiz, Spain. A total of 14 older adults participated, all of whom had previously taken part in the intervention group of the randomized experimental project called Fragsalud, which aimed to improve frailty through educational sessions. During that project, frailty was assessed using the Fried criteria, and physical condition, physical activity, and sleep were evaluated through accelerometry, as well as questionnaires on nutritional habits, depressive symptoms, social support, instrumental and basic activities of daily living, quality of life, cognition, and sleep, at the beginning of the study, at 6 months, and at the end of the study at 12 months. For the Fragbiota project, once Fragsalud was completed, participants were analyzed based on whether or not they responded to the educational intervention. That is, the gut microbiota of those subjects who, after 12 months, had reduced the Fried frailty criteria was compared with those who, despite receiving the educational intervention, had maintained the same Fried levels or had worsened. Furthermore, this gut microbiota was related to the secondary variables previously assessed in the Fragsalud project. This study complied with biomedical ethical guidelines, including Good Clinical Practice (CPMP/ICH/135/95), the Oviedo Convention, the Universal Declaration of Human Rights, CIOMS/WHO ethical guidelines, and the Declaration of Helsinki, ensuring the dignity, rights, and safety of participants. Additionally, participants provided informed consent after receiving detailed explanations, both in writing and verbally, regarding the objectives, procedures, and risks of the study.
- Conditions
- Frailty, Microbiota
- Being tested
- Fecal sample collection
- Keywords
- gut microbiota, older adults, educational program
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal sample collectionOther
Fecal samples were collected by the participants themselves at home, who were instructed to collect a small stool sample either on the morning of the delivery day or the evening of the previous day. For home sample collection, participants were provided with a fecal sample collection kit that included a hermetically sealed sterile container, a fecal sample stabilizer (reference SC0012, Canvax brand), gloves, and a small spoon. Participants were instructed to collect a small fecal sample using the spoon and place it into the container, mixing it by shaking to combine it with the stabilizer.
| Study group | Role | What they receive |
|---|---|---|
| Older adults who participated in an educational intervention program called FRAGSALUD | Participants who, after taking part in an educational intervention of a project called FRAGSALUD, either were considered as responders or non-responders to the intervention, measured if they could reduced their levels of Fried's frailty criteria. Receives: Other: Fecal sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota
Fecal samples will be collected by the participants themselves at home. For the determination of gut microbiota, the following steps will be carried out:
DNA Extraction: DNA will be extracted using the QIAamp DNA Stool Mini Kit (QIAGEN, Barcelona, Spain).
Sequencing: Polymerase Chain Reaction (PCR) will be used to amplify the extracted DNA with primers targeting the hypervariable V3 and V4 regions of the bacterial 16S rRNA gene, using the following primers: forward 16S Amplicon PCR primer: 5'TCGTCGGCAGCGTCAGATGTGTATAAGAGACAGCCTACGGGNGGCWGCAG, and reverse 16S Amplicon PCR primer: 5'GTCTCGTGGGCTCGGAGATGTGTATAAGAGACAGGACTACHVGGGTATCTAATCC.
Bioinformatic Analysis: Illumina bcl2fastq2 v2.20 software will be used to demultiplex the raw sequences, and the raw data will be imported into the open-source QIIME 2 2020.8 software.
Functional Profile Determination: PICRUSt2 will be used to predict potential functional profiles for the sequenced samples.
Measured: At 12 months after the completion of the study
Secondary outcomes (10)
Frailty Index
Through the Fried questionnaire, which includes five domains: i) unintentional weight loss, ii) self-reported exhaustion and fatigue, iii) low weekly physical activity measured using the short version of the Minnesota Leisure Time Physical Activity Questionnaire, iv) gait speed over 4.57 meters, and v) low grip strength measured with a hand-held dynamometer.
Measured: Day one and at 12 months after the completion of the study
Functional capacity or physical performance
Using the Short Physical Performance Battery (SPPB), balance was assessed (with the feet together, semi-tandem, and tandem tests), gait speed was measured (with the 4-meter walking test), and lower body strength was evaluated (with the five-times chair stand test).
Measured: Day one and at 12 months after the completion of the study
Functional dependence
Functional dependence was assessed using the Barthel Index, which is a reliable and validated tool designed to evaluate an individual's ability to perform ten Activities of Daily Living. These activities include feeding, transferring from a chair to the bed, bathing, dressing, grooming, bowel control, bladder control, using the toilet, walking, and climbing stairs. Additionally, the Lawton and Brody scale was applied, which is a reliable and validated tool used to assess Instrumental Activities of Daily Living, covering eight domains: use of the telephone, transportation, medication management, financial transactions, meal preparation, shopping, household maintenance, and laundry.
Measured: Day one and at 12 months after the completion of the study
Physical activity and sleep patterns
Measured using wrist-worn accelerometers (GENEActiv, ActivInsights Ltd., Kimbolton, UK), which participants wore for at least six consecutive days. The accelerometers were set to 60 Hz, and raw data were downloaded using GENEActiv software version 3.3. All raw data files were analyzed on the servers of the University of Málaga using the open-source R package GGIR, version 2.7-0. This R package auto-calibrated the data according to local gravity and calculated the Euclidean Norm Minus One (ENMO) for accelerations to minimize sensor calibration error.
Measured: Day one and at 12 months after the completion of the study
Subjective sleep
Using the Pittsburgh Sleep Quality Index, which has been validated in this population, the questionnaire includes 19 items assessing seven distinct dimensions of sleep. These dimensions include subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, use of sleep medication, and daytime dysfunction.
Measured: Day one and at 12 months after the completion of the study
Quality of life assessment
The EuroQoL 5-Dimension 5-Level (EQ-5D-5L) was used to assess health-related quality of life in the older participants. It consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), with participants rating each dimension on a five-point scale from 1 (no problems) to 5 (extreme problems). These ratings were combined into a five-digit number representing their health state. After generating 3,125 possible health states, a formula was used to convert them into a single health index ranging from 0 to 1, with 1 representing the maximum achievable score. In addition, the questionnaire included a Visual Analog Scale (VAS) to assess self-reported health levels. The VAS consisted of a scale from 0 (representing the worst imaginable health state) to 100 (representing the best imaginable health state), and participants were asked to indicate the score that best represented their health on the day of the assessment.
Measured: Day one and at 12 months after the completion of the study
Depressive symptoms
Through the 15-item Yesavage Geriatric Depression Scale (GDS-15), a validated assessment tool for depression in older adults. The GDS-15 uses a binary response format (yes or no) and evaluates only the cognitive symptoms of a major depressive episode experienced during the past 15 days, excluding somatic depressive symptoms such as sleep difficulties, changes in appetite, lack of concentration, and fatigue.
Measured: Day one and at 12 months after the completion of the study
Social support
Through the Duke-UNC Functional Social Support Questionnaire (Duke-UNC-11), which has been validated in the Spanish population.
Measured: Day one and at 12 months after the completion of the study
Cognitive function assessment
The cognitive status of the participants was assessed using the Portable Short Portable Mental Status Questionnaire (SPMSQ), which has demonstrated good validity and reliability in the Spanish population. This test is widely used due to its brevity and ease of administration, making it a rapid screening tool. It consists of 10 questions that evaluate short- and long-term memory, orientation, and the ability to perform serial mathematical tasks.
Measured: Day one and at 12 months after the completion of the study
Risk of malnutrition
Through the Mini-Nutritional Assessment (MNA). This evaluation includes questions related to various aspects such as lifestyle, medication, mobility, number of meals, food and fluid intake, independence in eating, and self-perception of health and nutrition.
Measured: Day one and at 12 months after the completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start25 Aug 2025
- Primary completion22 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación ASISA
- Responsible party
- Sponsor
- Investigators
- Cristina Casals Vázquez, Principal investigator, University of CádizJuan Corral Pérez, Principal investigator, University of Cádiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251322
- Sponsor's protocol ID
- FRAGBIOTA
- Acronym
- FRAGBIOTA
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Frailty and Gut Microbiota in Older Adults: Relevance for a Healthy Aging Education Program
- ClinicalTrials.gov ID
- NCT07251322
- Acronym / sponsor ID
- FRAGBIOTA / FRAGBIOTA
- Conditions
- Frailty, Microbiota
- Keywords
- gut microbiota, older adults, educational program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Collaborators
- Fundación ASISA
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 26 Nov 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 pre-experimental study is to describe the relationship between gut microbiota and changes in the degree of frailty in older adults who participated in an educational program. More specifically, the study aims to: determine the gut microbiota profile of community-dwelling older adults, both robust and frail; analyze the effect of a 12-month educational program on gut microbiota; examine the association of gut microbiota with physical function, functional dependency, and physical activity in frail or pre-frail older adults who received the program; investigate its relationship with the risk of malnutrition; relate the gut microbiota profile to quality of life, depressive symptoms, and social support; and, finally, associate gut microbiota with cognitive frailty and sleep quality in this group of older adults who participated in the health promotion educational intervention.
Detailed description
This non-randomized pre-experimental study was conducted in the province of Cádiz, Spain. A total of 14 older adults participated, all of whom had previously taken part in the intervention group of the randomized experimental project called Fragsalud, which aimed to improve frailty through educational sessions. During that project, frailty was assessed using the Fried criteria, and physical condition, physical activity, and sleep were evaluated through accelerometry, as well as questionnaires on nutritional habits, depressive symptoms, social support, instrumental and basic activities of daily living, quality of life, cognition, and sleep, at the beginning of the study, at 6 months, and at the end of the study at 12 months. For the Fragbiota project, once Fragsalud was completed, participants were analyzed based on whether or not they responded to the educational intervention. That is, the gut microbiota of those subjects who, after 12 months, had reduced the Fried frailty criteria was compared with those who, despite receiving the educational intervention, had maintained the same Fried levels or had worsened. Furthermore, this gut microbiota was related to the secondary variables previously assessed in the Fragsalud project. This study complied with biomedical ethical guidelines, including Good Clinical Practice (CPMP/ICH/135/95), the Oviedo Convention, the Universal Declaration of Human Rights, CIOMS/WHO ethical guidelines, and the Declaration of Helsinki, ensuring the dignity, rights, and safety of participants. Additionally, participants provided informed consent after receiving detailed explanations, both in writing and verbally, regarding the objectives, procedures, and risks of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults who participated in an educational intervention program called FRAGSALUD | – | Other: Fecal sample collectionParticipants who, after taking part in an educational intervention of a project called FRAGSALUD, either were considered as responders or non-responders to the intervention, measured if they could reduced their levels of Fried's frailty criteria. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- A cohort of participants of the FRAGSALUD project (older adults with at least one Fried's frailty criterion), that will be divided into to responders (if they reduced their levels of frailty) and non-responders (if they did not reduced their levels of frailty) after the FRAGSALUD intervention (an educactional program of four sessions and six telephone calls)
Key inclusion criteria (3 listed)
- Patients over 65 years of age who present frailty or pre-frailty, assessed using the Fried criteria adapted to the Spanish population
- Patients belonging to the Clinical Management Units participating in the study and who will remain in them for the 12 months of the study
- Patients who are able to attend the Health Center alone or accompanied
Key exclusion criteria (6 listed)
- COPD stage III or IV, unstable angina, uncontrolled congestive heart failure, or unstable arrhythmia
- Patients who cannot walk independently or with assistive devices, such as bedridden individuals
- Patients in nursing homes
- Patients with severe cognitive impairment
- Patients who do not understand Spanish or English
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 |
|---|---|---|
| Fecal sample collectionFecal samples were collected by the participants themselves at home, who were instructed to collect a small stool sample either on the morning of the delivery day or the evening of the previous day. For home sample collection, participants were provided with a fecal sample collection kit that included a hermetically sealed sterile container, a fecal sample stabilizer (reference SC0012, Canvax brand), gloves, and a small spoon. Participants were instructed to collect a small fecal sample using the spoon and place it into the container, mixing it by shaking to combine it with the stabilizer. | Other | Older adults who participated in an educational intervention program called FRAGSALUD |
Primary outcome
Gut microbiota
Time frame: At 12 months after the completion of the study
Fecal samples will be collected by the participants themselves at home. For the determination of gut microbiota, the following steps will be carried out: DNA Extraction: DNA will be extracted using the QIAamp DNA Stool Mini Kit (QIAGEN, Barcelona, Spain). Sequencing: Polymerase Chain Reaction (PCR) will be used to amplify the extracted DNA with primers targeting the hypervariable V3 and V4 regions of the bacterial 16S rRNA gene, using the following primers: forward 16S Amplicon PCR primer: 5'TCGTCGGCAGCGTCAGATGTGTATAAGAGACAGCCTACGGGNGGCWGCAG, and reverse 16S Amplicon PCR primer: 5'GTCTCGTGGGCTCGGAGATGTGTATAAGAGACAGGACTACHVGGGTATCTAATCC. Bioinformatic Analysis: Illumina bcl2fastq2 v2.20 software will be used to demultiplex the raw sequences, and the raw data will be imported into the open-source QIIME 2 2020.8 software. Functional Profile Determination: PICRUSt2 will be used to predict potential functional profiles for the sequenced samples.
10 secondary outcomes
Frailty Index
Time frame: Day one and at 12 months after the completion of the study
Functional capacity or physical performance
Time frame: Day one and at 12 months after the completion of the study
Functional dependence
Time frame: Day one and at 12 months after the completion of the study
Physical activity and sleep patterns
Time frame: Day one and at 12 months after the completion of the study
Subjective sleep
Time frame: Day one and at 12 months after the completion of the study
Quality of life assessment
Time frame: Day one and at 12 months after the completion of the study
Depressive symptoms
Time frame: Day one and at 12 months after the completion of the study
Social support
Time frame: Day one and at 12 months after the completion of the study
Cognitive function assessment
Time frame: Day one and at 12 months after the completion of the study
Risk of malnutrition
Time frame: Day one and at 12 months after the completion of the study
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 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
Cristina Casals Vázquez principal investigator
University of Cádiz
Juan Corral Pérez principal investigator
University of Cádiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Microbiota, run by University of Cadiz 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 3 inclusion and 6 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 26 Nov 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?
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?
Gut microbiota (time frame: At 12 months after the completion of the study). 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 26 Nov 2025.