Improving muscle health and cognitive function in older adults through gut microbiota optimization
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.
This study is testing whether giving older adults gut bacteria from young, healthy donors can help improve their muscle strength and brain function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 65 Years to 84 Years |
| Sex | All |
| Sponsor | University of Chile Academic / other |
| Locations | 2 sites (Santiago, Región Metropolitana and 1 other locations) |
| Trial ID | NCT06649981 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of fecal microbiota transplantation (FMT) from young, trained donors on muscle health and cognitive function in older adults aged 65-84. The study aims to determine whether modifying the gut microbiota can enhance resilience and reduce cognitive decline and metabolic dysfunction associated with aging. Participants will receive either FMT capsules or placebo capsules, and their muscle function, cognitive abilities, and overall well-being will be assessed throughout the trial. The approach is based on the premise that gut dysbiosis contributes to sarcopenia and that restoring a healthy microbiota may mitigate its effects.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65-84 who are self-sufficient and have stable health conditions.
Not a fit: Patients with significant health issues such as inflammatory bowel disease or those currently using antibiotics or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved muscle function and cognitive health in older adults, enhancing their quality of life.
How similar studies have performed: While the use of FMT for various conditions is being explored, this specific approach targeting muscle health and cognitive function in older adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Santiago, Región Metropolitana and 1 other locations
- Clínica Universidad de los Andes — Santiago, Región Metropolitana, Chile (Recruiting)
- INTA - Universidad de Chile — Santiago, Región Metropolitana, Chile (Recruiting)
Study contacts
- Principal investigator: Ricardo Espinoza, MD — Universidad de Los Andes
- Study coordinator: Gonzalo Jorquera, PhD
- Email: gonzalo.jorquera@inta.uchile.cl
- Phone: 56229781561
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.