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This study examines fecal microbiota transplantation (FMT) capsules, compared with placebo, aimed at optimizing gut microbiota in people aged 65-84. Self-sufficient older adults who can swallow capsules and meet certain health criteria may take part. It is a Phase 1 study that is currently active but not recruiting new participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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)