Probiotics and Active Aging: Enhancing Gut Health (PAAEGH)

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:

1. To determine the state of the gut flora in older adults through the analysis of the intestinal microbiota.
2. To identify changes in the intestinal microbiota resulting from the intake of probiotics in older adults.
3. To evaluate the effects of the intestinal microbiota in older adults participating in a training programme.
4. 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 Overview

• Status: Not yet recruiting
• Conditions: Healthy; Physical Activity; Older People; Mental Health; Physical Fitness; Gut -Microbiota; Probiotic
• Intervention / Treatment: Other: Dietary Supplement; Behavioral: Structured Physical Activity Program; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Luis Felipe, PhD; Phone Number: +34648885392; Email: joseluis.felipe@uclm.es
• Study Contact Backup: Name: Raquel Aparicio Mera, MsC; Phone Number: +34689061886; Email: raquel.aparicio@uclm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group - Physical Activity + Probiotics; 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.	Other: Dietary Supplement; 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.; Behavioral: Structured Physical Activity Program; 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.
Active Comparator: Control Group A - Sedentary + Probiotics; 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.	Other: Dietary Supplement; 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.
Placebo Comparator: Control Group B - Sedentary + Placebo; 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.	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 12, Week 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	Baseline, Week 12, Week 18
Change in handgrip strength	Measured using a hand dynamometer to assess upper body strength. Unit of measure: kilograms	Baseline, Week 12, Week 18
Change in body fat percentage	Measured using bioimpedance analysis to assess body composition. Unit of measure: percent (%)	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	Baseline, Week 12, Week 18

Collaborators and Investigators

• Sponsor: Jose Luis Felipe

Publications and helpful links

General Publications

• Barnett 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.
• 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.
• Aya 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.
• Nascimento 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.
• Marttinen 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 5, 2025
• First Submitted That Met QC Criteria: June 13, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; gut microbiota; older people
• Other Study ID Numbers: IGOID3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No