Active — Not RecruitingPhase 1

Aging Resilience Through Microbiota Optimization and Regulation

Chile80 participantsStarted 2025-01-10

Plain-language summary

Sarcopenia, characterized by the progressive loss of muscle mass and strength in older adults, is a key factor in health deterioration. It affects 15% of people between 65 and 80 years old and over 50% of those over 80, compromising autonomy and increasing the risk of diseases. Sarcopenia not only impacts muscle function but also bone health, mobility, and is associated with cardiometabolic diseases and cognitive decline. It has been proposed that changes in the gut microbiota in aging individuals, known as gut dysbiosis, contribute to sarcopenia. Species diversity decreases, and bacterial representation is altered, which could impair muscle function through various pathways, such as mitochondrial dysfunction, chronic inflammation, and disruption of protein synthesis. Muscle function loss is strongly associated with cognitive and metabolic impairment in older adults. Recently, it has been demonstrated that fecal microbiota transplantation (FMT) is an effective procedure for modulating gut microbiota and has proven highly effective in managing cases of Clostridium difficile-associated chronic diarrhea. The main objective of this project is to carry out FMT from young, physically active donors to a cohort of older adults to evaluate its effect on muscle, cognitive, and metabolic function. Why donors who exercise? There is growing evidence that gut microbiota diversity is increased in young, physically active individuals. The FMT is planned to be administered through lyophilized microbiota capsules. By restoring microbial diversity, it is expected to improve the quality and function of skeletal muscles, leading to greater cognitive and metabolic resilience. This project has great potential to develop an innovative approach for treating highly debilitating diseases that affect older adults, based on the lyophilization and encapsulation of gut microbiota from young, trained donors, which can be easily stored in a conventional freezer. Due to the high percentage of older adults worldwide and the high prevalence of sarcopenia within this age group, the aim of the project is to address a significant public health issue with a large target population eager for options to promote muscle health, functional autonomy, as well as cognitive and metabolic well-being.

Who can participate

Age range

65 Years – 84 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Individuals aged 65-84 years * Men and women * Involuntary total body weight variation in the last 6 months \< 10% * Self-sufficiency (with a score \>60 on the Barthel index) * Fasting plasma glucose ≤ 7.2 mmol/l or glycosylated hemoglobin (HbA1c) ≤ 8% in the last 6 months. * Must be able to swallow capsules Exclusion Criteria: * Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg at selection * Allergy to rifaximin * Acute infection or inflammatory condition in the last 4 weeks * Use of antibiotics in the last 12 weeks * Use of probiotics in the last 12 weeks * Hospitalization in the last 12 weeks * Current or within the last 6 months use of insulin * Difficulty swallowing (dysphagia) * Diagnosis of Inflammatory bowel disease * Diagnosis of Crohn's disease * Diagnosis of Ulcerative colitis * Diagnosis of Clostridium difficile infection * Diagnosis of Colon cancer * Treatment with immunosuppressive therapy for organ transplant * Diagnosis of leukemia * Diagnosis of lymphoma * Diagnosis of mesenchymal diseases except osteoarthritis * Corticosteroid users * Biological therapy users * Individuals with a history of autoimmune or chronic inflammatory conditions (rheumatoid arthritis, chronic or active hepatitis B or C, human immunodeficiency virus, pancreatitis, or liver cirrhosis) * Individuals with an active malignancy, * Current drug or alcohol abuse (more than three drinks per day or more than seven drinks per week). * Diagnosis o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Isometric strength

Timeframe: Before and after FMT (4-20 weeks follow-up)

Functional Autonomy: Global Index of the Latin American Group for Maturity (GDLAM)

Timeframe: Before and after FMT (4-20 weeks follow-up)

Adverse effects after FMT registration

Timeframe: after FMT (4-20 weeks follow-up)

Trial details

NCT IDNCT06649981

SponsorGonzalo Jorquera, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-17

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