Probiotics and Active Aging: Enhancing Gut Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of GI BIOTICS 100B UFC to Improve Intestinal Health in Older Adults

NCT06396728

Gut Microbiota Gut Health Digestive System +2 more

NOT_YET_RECRUITING NA

The Effect of Probiotics on the Improvement of Digestive Function and Well-being in the Elderly

NCT06648590

People Aged 55-70 Years

COMPLETED NA

The Impact of Probiotics on Well-being in Women

NCT06507111

Female Healthy Aging

COMPLETED NA

the Effect of Probiotics on Aging Population

NCT04911556

Debility

UNKNOWN NA

Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

NCT01667653

Antibiotic Therapy

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

In this double-blind study, both participants and outcomes assessors are masked to the intervention assignment. The probiotic and placebo capsules are identical in appearance, taste, and packaging, ensuring that participants cannot distinguish between them. Outcomes assessors responsible for evaluating physical condition, microbiota composition, and quality of life are also blinded to group allocation to minimize assessment bias. The investigators administering the interventions are not blinded due to logistical requirements in distributing the correct supplement.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Dietary Supplement

Intervention Type 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.

Structured Physical Activity Program

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Dietary Supplement

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes