NCT07033637

Probiotics and Active Aging: Enhancing Gut Health

Promoting Health Through Symbiosis: Exploring the Relationship Between Gut Microbiota, Probiotics, and Physical Activity in Older Adults

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Jose Luis Felipe · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Gut -Microbiota
• Older People
• Physical Activity
• Physical Fitness
• Mental Health
• Probiotic
• Healthy

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-01-31
• Completion: 2026-06-30
• First posted: 2025-06-24
• Last updated: 2025-06-24