The Characteristics of Gut Microbiota in Patients With Sarcopenia and the Development of Probiotics
Recruiting now
Conditions studied: Sarcopenia
In brief
The primary aim of this study is to identify the composition and characteristics of the gut microbiota in patients with sarcopenia in older adults, and compare these with the gut microbiota characteristics of older adults and young control groups to determine differences. Secondary purpose of this study is to provide data on the characteristics of gut microbiota for the development of probiotics effective in treating sarcopenia in older adults.
Key facts
- Study ID
- NCT07334210
- Run by
- Seoul National University Bundang Hospital
- People needed
- 150
- Starts
- 2025-06-13
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2026-01-12
Who can join
Age: 20 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Sarcopenia patient group
- Individuals aged 65 to 90 years
- Meet the diagnostic criteria for sarcopenia based on the 2019 Asian Working Group for Sarcopenia (AWGS) guidelines:
- Low appendicular skeletal muscle mass
- DEXA: <7.0 kg/m² (men), <5.4 kg/m² (women)
- BIA: <7.0 kg/m² (men), <5.7 kg/m² (women)
- Low muscle strength
- Handgrip strength: <28 kg (men), <18 kg (women) or
- Low physical performance
- 6-meter walk speed <1.0 m/s
- 5-chair stand test ≥12 seconds
- Short Physical Performance Battery (SPPB) score ≤9
- Voluntarily agree to participate in the clinical study and sign the informed consent form
- Older adult control group
- Individuals aged 65 to 90 years
- Voluntarily agree to participate in the clinical study and sign the informed consent form
- Young adult control group
- Individuals aged 20 to 50 years
- Voluntarily agree to participate in the clinical study and sign the informed consent form
You may not qualify if…
- Individuals currently under treatment for severe diseases of the cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal/urinary, neurological, psychiatric systems, infectious diseases, or malignant tumors (Exception: skin tumors other than melanoma are excluded; cancer survivors may participate if more than 5 years have passed since complete remission).
- Individuals who have difficulty performing independent activities of daily living due to musculoskeletal or neurological diseases, or cognitive impairment (e.g., those with spinal disorders requiring surgery or having walking limitations).
- Individuals who regularly consume alcohol according to WHO daily intake standards (≥ 40 g/day for men, ≥ 20 g/day for women).
- Heavy smokers (≥ 20 cigarettes/day).
- Individuals with AST (GOT) or ALT (GPT) levels ≥ 3 times the upper limit of normal established by the testing institution.
- Patients with uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, measured after the subject has rested for 10 minutes).
- Patients with uncontrolled diabetes mellitus (HbA1c > 7.0%).
- Individuals with TSH ≤ 0.1 μIU/mL or ≥ 10 μIU/mL.
- Individuals deemed unsuitable for other reasons at the discretion of the investigator.
Where it is running
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (enrolling)
Full record on ClinicalTrials.gov
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