Gut -MicrobiotaPAAEGHNCT07033637
Probiotics and Active Aging: Enhancing Gut Health
A study testing Dietary Supplement and Structured Physical Activity Program in people with Gut -Microbiota and Older People, run by Jose Luis Felipe.
Trial summary
The general objective of this clinical trial is to assess the physical fitness and gut microbiota of older adults, thereby highlighting the importance of focusing on health maintenance. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut -Microbiota, Older People, Physical Activity
- What is being tested?
- Dietary Supplement and Structured Physical Activity Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Jun 2026
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 60 years or older.
- Residents of Castilla-La Mancha or Madrid.
- Able to provide informed consent.
- For the intervention group: enrolled in a municipal physical activity program with a minimum frequency of 2 sessions per week.
- Willing to participate in all assessments and follow study instructions.
- Consent: Participants must provide written informed consent to participate in the study.
Who cannot join
- Recent serious musculoskeletal injuries (e.g., muscle tears, ligament ruptures, fractures).
- Current symptoms during exercise such as chest pain, dizziness, or joint pain.
- Uncontrolled hypertension (≥160/100 mmHg).
- Recent cardiac failure or infectious disease (e.g., meningitis, hepatitis, flu).
- Chronic gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, IBS).
- Regular use of medications affecting gut motility or microbiota (e.g., laxatives >3 times/week).
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- Immunodeficiency (e.g., HIV, active cancer).
- Use of antibiotics (oral or parenteral) within 4 weeks prior to the study.
- Regular intake of probiotic supplements or foods (e.g., Actimel) within 2 weeks prior to the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Promoting Health Through Symbiosis: Exploring the Relationship Between Gut Microbiota, Probiotics, and Physical Activity in Older Adults
The general objective of this clinical trial is to assess the physical fitness and gut microbiota of older adults, thereby highlighting the importance of focusing on health maintenance. By making use of available resources and fostering collaboration among the elements involved in the study, more specific objectives can be defined:
- To determine the state of the gut flora in older adults through the analysis of the intestinal microbiota.
- To identify changes in the intestinal microbiota resulting from the intake of probiotics in older adults.
- To evaluate the effects of the intestinal microbiota in older adults participating in a training programme.
- To assess the physical fitness and perceived quality of life in older adults who engage in sport activities supported by technology.
Read more
Participants will:
- Perform physical tests such as the 6-Minute Walk Test (6MWT), the Timed Up and Go (TUG), and the Sit-to-Stand test.
- Complete wellbeing questionnaires to assess their perceived quality of life and health status.
- Complete dietary habit questionnaires.
- Provide stool samples for microbiota analysis.
- Take part in exercise interventions or placebo exercise sessions, depending on their assigned group.
- Conditions
- Gut -Microbiota, Older People, Physical Activity, Physical Fitness, Mental Health, Probiotic
- Being tested
- Dietary Supplement, Placebo, Structured Physical Activity Program
- Keywords
- older people, gut microbiota, physical activity
- Medical subject headings
- Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary SupplementOther
A daily oral capsule containing 1 x 10⁹ CFU of Lactiplantibacillus plantarum CECT 7481 (32.5 mg), microcrystalline cellulose (304.1 mg), and magnesium stearate (3.4 mg). Administered once daily before the main meal for 6 weeks. Used to evaluate its effects on gut microbiota and physical health in older adults.
PlaceboOther
A daily oral capsule identical in appearance to the probiotic capsule, containing maltodextrin instead of Lactiplantibacillus plantarum. Administered once daily before the main meal for 6 weeks. Used to control for placebo effects in the assessment of probiotic efficacy.
Structured Physical Activity ProgramBehavioural
A 12-week supervised physical activity program conducted at municipal sports centers. Participants engage in moderate-intensity exercise at least 2 times per week. Designed to assess the impact of physical activity on gut microbiota, physical condition, and quality of life in older adults.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Physical Activity + Probiotics | Experimental | Participants in this arm will engage in a structured physical activity program for 12 weeks, followed by a 6-week period during which they will continue the exercise regimen and begin daily intake of a probiotic supplement (AB-DR7, containing Lactiplantibacillus plantarum CECT 7481). The goal is to assess the combined effects of physical activity and probiotics on gut microbiota, physical condition, and quality of life in older adults. Receives: Other: Dietary Supplement; Behavioral: Structured Physical Activity Program |
| Control Group A - Sedentary + Probiotics | Active comparator | Participants in this arm will maintain their usual sedentary lifestyle throughout the study. After the initial 12-week observation period, they will begin a 6-week daily intake of the same probiotic supplement (AB-DR7). This arm is used to evaluate the effects of probiotics alone on gut microbiota and health indicators in the absence of physical activity. Receives: Other: Dietary Supplement |
| Control Group B - Sedentary + Placebo | Placebo comparator | Participants in this arm will maintain a sedentary lifestyle and receive a placebo capsule identical in appearance to the probiotic, but containing maltodextrin instead of Lactiplantibacillus plantarum. This group serves as the baseline comparator to assess the natural variation in outcomes without intervention. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut microbiota composition
Assessment of gut microbiota diversity and composition using 16S rRNA sequencing of stool samples. Alpha and beta diversity indices will be calculated to evaluate changes over time and between groups.
Measured: Baseline, Week 12, Week 18
Secondary outcomes (6)
Change in quality of life scores
The Short Form Health Survey - 12 items (SF-12) is a validated, self-reported instrument used to assess health-related quality of life. It generates two composite scores:
- Physical Component Summary (PCS-12)
- Mental Component Summary (MCS-12)
Score range: Norm-based scoring with a mean of 50 and a standard deviation of 10 in the general population.
Interpretation:
- Scores above 50 indicate better-than-average health-related quality of life.
- Scores below 50 indicate worse-than-average health-related quality of life
Measured: Baseline, Week 12, Week 18
Change in gastrointestinal symptom scores
Measured using the GSRS (Gastrointestinal Symptom Rating Scale), which includes 15 items grouped into five symptom clusters.
Score range: 1 to 7 Interpretation: Higher scores reflect greater severity of gastrointestinal symptoms.
Measured: Baseline, Week 12, Week 18
Change in 6-minute walk test distance
Distance walked in meters during the 6-minute walk test to assess cardiorespiratory fitness.
Unit of measure: meters
Measured: Baseline, Week 12, Week 18
Change in handgrip strength
Measured using a hand dynamometer to assess upper body strength.
Unit of measure: kilograms
Measured: Baseline, Week 12, Week 18
Change in body fat percentage
Measured using bioimpedance analysis to assess body composition.
Unit of measure: percent (%)
Measured: Baseline, Week 12, Week 18
Change in balance performance
Measured using a pressure platform during a 30-second Romberg test. The outcome includes center of pressure displacement and bilateral weight distribution to assess balance and fall risk.
Unit of measure: Sway Index
Measured: Baseline, Week 12, Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gut -MicrobiotaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This interventional study follows a parallel assignment model with three distinct groups of older adults (≥60 years), each comprising 30 participants: Group 1 (Intervention Group): Participants engage in a structured physical activity program and later receive a probiotic supplement (AB-DR7). Group 2 (Control Group A): Sedentary participants who receive the probiotic supplement without engaging in physical activity. Group 3 (Control Group B): Sedentary participants who receive a placebo and do not engage in physical activity. The study is conducted over 18 weeks, divided into two main phases: First 12 weeks: Group 1 performs physical activity; Groups 2 and 3 maintain their usual sedentary lifestyle. Following 6 weeks: Groups 1 and 2 begin probiotic intake; Group 3 continues with placebo. The model is designed to evaluate the independent and combined effects of physical activity and probiotic supplementation on gut microbiota composition, physical condition, and quality of life in old
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jose Luis Felipe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Luis Felipe, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033637
- Sponsor's protocol ID
- IGOID3
- Acronym
- PAAEGH
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and the nature of the study being part of a doctoral thesis. The data are collected under strict confidentiality agreements and are intended solely for internal analysis and academic purposes within the research team. Any future data sharing would require additional ethical approvals and participant consent.
Publications
Thomas E, Battaglia G, Patti A, Brusa J, Leonardi V, Palma A, Bellafiore M. Physical activity programs for balance and fall prevention in elderly: A systematic review. Medicine (Baltimore). 2019 Jul;98(27):e16218. doi: 10.1097/MD.0000000000016218.
PubMed 31277132Nascimento V, Fonseca C, Pinho LG, Lopes MJ. Person-Centered Health Intervention Programs, Provided at Home to Older Adults with Multimorbidity and Their Caregivers: Protocol for a Systematic Review. J Pers Med. 2022 Dec 23;13(1):27. doi: 10.3390/jpm13010027.
PubMed 36675688Marttinen M, Ala-Jaakkola R, Laitila A, Lehtinen MJ. Gut Microbiota, Probiotics and Physical Performance in Athletes and Physically Active Individuals. Nutrients. 2020 Sep 25;12(10):2936. doi: 10.3390/nu12102936.
PubMed 32992765Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet. 2012 Jul 7;380(9836):37-43. doi: 10.1016/S0140-6736(12)60240-2. Epub 2012 May 10.
PubMed 22579043Aya V, Jimenez P, Munoz E, Ramirez JD. Effects of exercise and physical activity on gut microbiota composition and function in older adults: a systematic review. BMC Geriatr. 2023 Jun 12;23(1):364. doi: 10.1186/s12877-023-04066-y.
PubMed 37308839
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Health Through Symbiosis: Exploring the Relationship Between Gut Microbiota, Probiotics, and Physical Activity in Older Adults
- ClinicalTrials.gov ID
- NCT07033637
- Acronym / sponsor ID
- PAAEGH / IGOID3
- Conditions
- Gut -Microbiota, Older People, Physical Activity, Physical Fitness, Mental Health, Probiotic
- Keywords
- older people, gut microbiota, physical activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jose Luis FelipeUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Jun 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 general objective of this clinical trial is to assess the physical fitness and gut microbiota of older adults, thereby highlighting the importance of focusing on health maintenance. By making use of available resources and fostering collaboration among the elements involved in the study, more specific objectives can be defined:
- To determine the state of the gut flora in older adults through the analysis of the intestinal microbiota.
- To identify changes in the intestinal microbiota resulting from the intake of probiotics in older adults.
- To evaluate the effects of the intestinal microbiota in older adults participating in a training programme.
- To assess the physical fitness and perceived quality of life in older adults who engage in sport activities supported by technology.
Participants will:
- Perform physical tests such as the 6-Minute Walk Test (6MWT), the Timed Up and Go (TUG), and the Sit-to-Stand test.
- Complete wellbeing questionnaires to assess their perceived quality of life and health status.
- Complete dietary habit questionnaires.
- Provide stool samples for microbiota analysis.
- Take part in exercise interventions or placebo exercise sessions, depending on their assigned group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This interventional study follows a parallel assignment model with three distinct groups of older adults (≥60 years), each comprising 30 participants: Group 1 (Intervention Group): Participants engage in a structured physical activity program and later receive a probiotic supplement (AB-DR7). Group 2 (Control Group A): Sedentary participants who receive the probiotic supplement without engaging in physical activity. Group 3 (Control Group B): Sedentary participants who receive a placebo and do not engage in physical activity. The study is conducted over 18 weeks, divided into two main phases: First 12 weeks: Group 1 performs physical activity; Groups 2 and 3 maintain their usual sedentary lifestyle. Following 6 weeks: Groups 1 and 2 begin probiotic intake; Group 3 continues with placebo. The model is designed to evaluate the independent and combined effects of physical activity and probiotic supplementation on gut microbiota composition, physical condition, and quality of life in old
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Physical Activity + Probiotics | Experimental | Other: Dietary Supplement, Behavioral: Structured Physical Activity ProgramParticipants in this arm will engage in a structured physical activity program for 12 weeks, followed by a 6-week period during which they will continue the exercise regimen and begin daily intake of a probiotic supplement (AB-DR7, containing Lactiplantibacillus plantarum CECT 7481). The goal is to assess the combined effects of physical activity and probiotics on gut microbiota, physical condition, and quality of life in older adults. |
| Control Group A - Sedentary + Probiotics | Active comparator | Other: Dietary SupplementParticipants in this arm will maintain their usual sedentary lifestyle throughout the study. After the initial 12-week observation period, they will begin a 6-week daily intake of the same probiotic supplement (AB-DR7). This arm is used to evaluate the effects of probiotics alone on gut microbiota and health indicators in the absence of physical activity. |
| Control Group B - Sedentary + Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will maintain a sedentary lifestyle and receive a placebo capsule identical in appearance to the probiotic, but containing maltodextrin instead of Lactiplantibacillus plantarum. This group serves as the baseline comparator to assess the natural variation in outcomes without intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 60 years or older.
- Residents of Castilla-La Mancha or Madrid.
- Able to provide informed consent.
- For the intervention group: enrolled in a municipal physical activity program with a minimum frequency of 2 sessions per week.
- Willing to participate in all assessments and follow study instructions.
Key exclusion criteria (9 listed)
- Recent serious musculoskeletal injuries (e.g., muscle tears, ligament ruptures, fractures).
- Current symptoms during exercise such as chest pain, dizziness, or joint pain.
- Uncontrolled hypertension (≥160/100 mmHg).
- Recent cardiac failure or infectious disease (e.g., meningitis, hepatitis, flu).
- Chronic gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, IBS).
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 |
|---|---|---|
| Dietary SupplementA daily oral capsule containing 1 x 10⁹ CFU of Lactiplantibacillus plantarum CECT 7481 (32.5 mg), microcrystalline cellulose (304.1 mg), and magnesium stearate (3.4 mg). Administered once daily before the main meal for 6 weeks. Used to evaluate its effects on gut microbiota and physical health in older adults. | Other | Control Group A - Sedentary + Probiotics, Intervention Group - Physical Activity + Probiotics |
| PlaceboA daily oral capsule identical in appearance to the probiotic capsule, containing maltodextrin instead of Lactiplantibacillus plantarum. Administered once daily before the main meal for 6 weeks. Used to control for placebo effects in the assessment of probiotic efficacy. | Other | Control Group B - Sedentary + Placebo |
| Structured Physical Activity ProgramA 12-week supervised physical activity program conducted at municipal sports centers. Participants engage in moderate-intensity exercise at least 2 times per week. Designed to assess the impact of physical activity on gut microbiota, physical condition, and quality of life in older adults. | Behavioural | Intervention Group - Physical Activity + Probiotics |
Primary outcome
Change in gut microbiota composition
Time frame: Baseline, Week 12, Week 18
Assessment of gut microbiota diversity and composition using 16S rRNA sequencing of stool samples. Alpha and beta diversity indices will be calculated to evaluate changes over time and between groups.
6 secondary outcomes
Change in quality of life scores
Time frame: Baseline, Week 12, Week 18
Change in gastrointestinal symptom scores
Time frame: Baseline, Week 12, Week 18
Change in 6-minute walk test distance
Time frame: Baseline, Week 12, Week 18
Change in handgrip strength
Time frame: Baseline, Week 12, Week 18
Change in body fat percentage
Time frame: Baseline, Week 12, Week 18
Change in balance performance
Time frame: Baseline, Week 12, Week 18
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 24 Jun 2025.
- Background: PubMed 31277132Thomas E, Battaglia G, Patti A, Brusa J, Leonardi V, Palma A, Bellafiore M. Physical activity programs for balance and fall prevention in elderly: A systematic review. Medicine (Baltimore). 2019 Jul;98(27):e16218. doi: 10.1097/MD.0000000000016218.
- Background: PubMed 36675688Nascimento V, Fonseca C, Pinho LG, Lopes MJ. Person-Centered Health Intervention Programs, Provided at Home to Older Adults with Multimorbidity and Their Caregivers: Protocol for a Systematic Review. J Pers Med. 2022 Dec 23;13(1):27. doi: 10.3390/jpm13010027.
- Background: PubMed 32992765Marttinen M, Ala-Jaakkola R, Laitila A, Lehtinen MJ. Gut Microbiota, Probiotics and Physical Performance in Athletes and Physically Active Individuals. Nutrients. 2020 Sep 25;12(10):2936. doi: 10.3390/nu12102936.
- Background: PubMed 22579043Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet. 2012 Jul 7;380(9836):37-43. doi: 10.1016/S0140-6736(12)60240-2. Epub 2012 May 10.
- Background: PubMed 37308839Aya V, Jimenez P, Munoz E, Ramirez JD. Effects of exercise and physical activity on gut microbiota composition and function in older adults: a systematic review. BMC Geriatr. 2023 Jun 12;23(1):364. doi: 10.1186/s12877-023-04066-y.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and the nature of the study being part of a doctoral thesis. The data are collected under strict confidentiality agreements and are intended solely for internal analysis and academic purposes within the research team. Any future data sharing would require additional ethical approvals and participant consent.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement and Structured Physical Activity Program in people with Gut -Microbiota and Older People, run by Jose Luis Felipe.
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 6 inclusion and 9 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Jose Luis Felipe, PhD (+34648885392, joseluis.felipe@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiota composition (time frame: Baseline, Week 12, Week 18). 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 NCT07033637, which also lists 5 linked publications.
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 24 Jun 2025.