Aging Resilience Through Microbiota Optimization and Regulation

Launched by GONZALO JORQUERA, PHD · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to improve muscle strength and overall health in older adults. Researchers believe that changes in the gut bacteria, or microbiota, as people age can contribute to the loss of muscle and strength, a condition known as sarcopenia. The trial will use a treatment called fecal microbiota transplantation (FMT), where healthy bacteria from young, physically active donors are delivered in capsule form to older participants. The goal is to see if restoring a healthier balance of gut bacteria can enhance muscle function, cognitive abilities, and overall well-being.

To be eligible for the trial, participants need to be between 65 and 84 years old, in generally good health, and able to swallow capsules. They should not have experienced significant weight changes recently and must be self-sufficient in daily activities. Participants can expect to receive the treatment and be monitored for its effects on their muscle and cognitive function. This trial aims to offer a potential new solution for improving health and independence in older adults facing sarcopenia, which is a growing concern as the population ages.

Gender

ALL

Eligibility 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)