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ACTIVE NOT RECRUITING

NCT06649981

PHASE1

Aging Resilience Through Microbiota Optimization and Regulation

Sponsor: Gonzalo Jorquera, PhD

View on ClinicalTrials.gov

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.

Official title: Intestinal Microbiota Transplant as a Strategy to Enhance the Resilience Capacity of the Elderly Aiming to Retain Muscular, Cognitive, and Metabolic Functions in a Stressful Environment.

Key Details

Gender

All

Age Range

65 Years - 84 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-01-10

Completion Date

2027-09-30

Last Updated

2026-01-21

Healthy Volunteers

Yes

Conditions

Resilience Cognitive Function and Well-Being Muscle Function, Handgrip Strength Test Insulin Sensitivity

Interventions

DIETARY_SUPPLEMENT

FMT capsule

A lyophilized gut microbiota capsule derived from a rigorously screened, healthy, and physically active donor, free of gastrointestinal diseases, antibiotic use, and chronic conditions. The donor diverse microbiome is supported by a nutrient-rich diet and active lifestyle. The lyophilization process preserves microbial integrity, offering a high-potency dose aimed at restoring and optimizing the gut microbiome of older adults. This intervention is specifically designed for older adults to enhance resilience to stress, cognitive function, muscular strength, and metabolic health. It is part of a controlled clinical study with follow-up assessments at weeks 1, 4, 8, and 20 post-intervention. This targeted approach distinguishes it from other microbiome-based therapies by focusing on comprehensive health benefits for an aging population.

DIETARY_SUPPLEMENT

Placebo Capsule(s)

A placebo capsule will be used in this study to serve as a control, allowing us to objectively assess the true effects of the lyophilized gut microbiota intervention. The use of a placebo is essential to eliminate bias and ensure that any observed outcomes can be confidently attributed to the actual intervention rather than to psychological or other non-specific effects. The placebo capsule will be identical in appearance, size, shape, and color to the interventional capsule to maintain blinding for both participants and researchers. This ensures that neither group knows which capsule is being administered, thereby preserving the study's integrity and validity by preventing any expectations or beliefs from influencing the results.

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 of dementia (To assess the presence of this disease at the time of enrollment, the following questions will be asked: Have you been diagnosed with dementia? \_\_\_Yes \_\_\_ No Do you take any of these medications? * Donepezil \_\_\_Yes \_\_\_No * Rivastigmine \_\_\_Yes \_\_\_No If the answer is positive to any of these questions, the patient will be excluded from the study. If there are doubts about the cognitive status of the potential participant by the recruiter, a Mini-Mental State Examination (MMSE) will be conducted, and the score must be ≥ 20)

Locations (2)

Clínica Universidad de los Andes

Santiago, Santiago Metropolitan, Chile

INTA - Universidad de Chile