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NCT Number: NCT07033637

Probiotics and Active Aging: Enhancing Gut Health

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.

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Key information

Conditions

Gut -Microbiota Behavior Healthy Mental Health Motor Activity Older People Personal Satisfaction Physical Activity Physical Fitness Probiotic Psychological Well-Being

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Supplement

Other

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

Other

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 Program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in quality of life scores

    Time frame: Baseline, Week 12, Week 18

    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

  2. Change in gastrointestinal symptom scores

    Time frame: Baseline, Week 12, Week 18

    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.

  3. Change in 6-minute walk test distance

    Time frame: Baseline, Week 12, Week 18

    Distance walked in meters during the 6-minute walk test to assess cardiorespiratory fitness.

    Unit of measure: meters

  4. Change in handgrip strength

    Time frame: Baseline, Week 12, Week 18

    Measured using a hand dynamometer to assess upper body strength.

    Unit of measure: kilograms

  5. Change in body fat percentage

    Time frame: Baseline, Week 12, Week 18

    Measured using bioimpedance analysis to assess body composition.

    Unit of measure: percent (%)

  6. Change in balance performance

    Time frame: Baseline, Week 12, Week 18

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jose Luis Felipe, PhD

CONTACT

[email protected]

+34648885392

Raquel Aparicio Mera, MsC

CONTACT

[email protected]

+34689061886

Sponsors and collaborators

Lead sponsor

Jose Luis Felipe

Other

Registry information

Official study title

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

Acronym: PAAEGH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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