Sarcopenia
Conditions
Interventions
Control group:Placebo Transplantation (Oral Placebo Capsule)
FMT group:Fecal Microbiota Transplantation (Oral Fecal Microbiota Transplantation Capsule)
Sponsors
West China Hospital, Sichuan Province
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Donors: 1. Voluntarily participate in the trial and sign the informed consent form; 2. Aged between 18 and 40 years, regardless of gender; 3. Have not taken medications (such as antibiotics, antiviral, antifungal drugs, hormones, immunosuppressants, chemotherapy drugs, weight-loss drugs, etc. Excluding contraceptives) in the past 6 months; 4. Have not engaged in high-risk sexual behavior (such as sexual contact with HIV patients, drug users, or individuals with syphilis) in the past 6 months; 5. Have no tattoos or piercings; 6. Have no history of infectious diseases (such as hepatitis, syphilis, HIV, tuberculosis, malaria, schistosomiasis, etc.) or travel history to endemic areas of infectious diseases; 7. Have no acute or chronic intestinal diseases (such as acute or chronic enteritis, functional bowel diseases, inflammatory bowel diseases, intestinal malignancies, etc.); 8. Have no history of drug abuse; 9. Have no oral diseases (caries, periodontal disease, mucosal diseases, or oral cancer); 10. Have no history of mental illness, with normal recent Hamilton Anxiety and Depression Rating Scale score; 11. Regular, well formed, and smooth bowel movements. Inclusion Criteria for Recipients: 1. Voluntarily participate in the trial and sign the informed consent form; 2. Individuals diagnosed with sarcopenia according to the 2019 Asian sarcopenia criteria.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Donors: 1. BMI > 28 kg/m² or BMI < 18.5 kg/m²;2. Atopic diseases (such as allergic rhinitis, allergic asthma, atopic dermatitis, etc.);3. Psychological disorders such as depression, anxiety, and diseases requiring maintenance therapy with medication; 4. Chronic diseases (such as cirrhosis, diabetes, hypertension, coronary heart disease, asthma, chronic obstructive pulmonary disease, etc.); 5. Neurological or neurodegenerative diseases; 6. Autoimmune diseases (such as celiac disease, arthritis, multiple sclerosis, connective tissue diseases, psoriasis); 7. History of gastrointestinal surgery (except appendectomy); 8. Family history (siblings and parents) of the following diseases: Crohn's disease, ulcerative colitis, celiac disease, colorectal cancer, polyposis, diabetes, psychological disorders, and other genetic diseases; 9. Gastrointestinal discomfort in the past month, including any moderate to severe upper gastrointestinal discomfort, diarrhea, constipation, moderate to severe abdominal bloating, moderate to severe nausea, painful bowel movements, mucous in stool, blood in stool, or any signs of blood related to bowel movements; 10. History of laxative use or intestinal lavage for beauty purposes in the past 3 months. Exclusion Criteria for Recipients: 1. Individuals with mental and consciousness disorders, severe cognitive impairment, and unable to effectively communicate; 2. Poor compliance, unable to cooperate with the completion of assessments and interventions; 3. Patients in the terminal stage of illness; 4. Individuals with allergies to this product or other drugs, foods, or substances; 5. Patients with epilepsy, severe renal insufficiency, dehydration, oliguria, or anuria; 6. Individuals who have participated in other clinical trials within the 3 months prior to enrollment; those who have taken medications with a significant impact on intestinal flora (such as antibiotics) within 1 month prior to enrollment; 7. Individuals with moderate esophageal varices; 8. Patients with severe intestinal barrier damage due to sepsis, active massive gastrointestinal bleeding, perforations, or other causes related to various reasons; 9. Individuals currently diagnosed with fulminant colitis or toxic megacolon; 10. Individuals unable to tolerate enteral nutrition meeting 50% of caloric needs due to severe diarrhea, significant fibrous luminal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistulas, or other reasons; 11. Patients with congenital or acquired immunodeficiency diseases; 12. Individuals who have recently received high-risk immunosuppressive or cytotoxic drug treatments: such as rituximab, doxorubicin, or medium to high doses of corticosteroid hormones (20 mg/day of prednisone or higher) for more than 4 weeks; 13. Individuals with severe immunosuppression; 14. Individuals with other conditions deemed excludable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skeletal Muscle Mass Index (SMI);grip strength;gait speed; | — |
Secondary
| Measure | Time frame |
|---|---|
| The score of SPPB scale;Calf Circumference; | — |
Countries
China
Contacts
Public ContactXiaolei Liu
West China Hospital of Sichuan University
Outcome results
None listed