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NCT Number: NCT07334210

The Characteristics of Gut Microbiota in Patients With Sarcopenia and the Development of Probiotics

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location status: Recruiting

About this study

Sarcopenia is a condition characterized by the loss of skeletal muscle mass and decline in physical function associated with aging. It is closely related to chronic diseases and geriatric disease and it is known to increase the risk of frailty, disability, falls, fractures, and mortality. The microbiome is closely associated with a wide range of human diseases, including metabolic disorders, cancer, infectious diseases, and immune-related conditions, and is considered one of the most valuable biomarkers for disease prevention and diagnosis. This indicates growing global interest and research activity on the connection between sarcopenia and gut microbiota. Through this study, we expect to elucidate the relationship between age-related sarcopenia and gut microbiota, which may provide important clues for the diagnosis and treatment of this condition.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Alpha diversity analysis values

    Time frame: Baseline (visit 1)

    Alpha diversity analysis values (Rarefaction and Boxplot) of gut microbiota in each group

  2. Short Physical Performance Battery (SPPB)

    Time frame: Screening(Visit 0)

    Short Physical Performance Battery (SPPB) results for sarcopenia physical performance evaluation in each group

Secondary outcomes

  1. Beta diversity analysis values

    Time frame: Baseline(Visit 1)

    Beta diversity analysis values of gut microbiota (PCoA plot)

  2. Taxa plot

    Time frame: Baseline(Visit 1)

    Taxa plot (Relative abundance) analysis values

  3. Handgrip strength

    Time frame: Screening(Visit 0)

    Handgrip strength

  4. 6-meter walking speed

    Time frame: Screening(Visit 0)

    6-meter walking speed

  5. appendicular skeletal muscle mass

    Time frame: Screening(Visit 0)

    appendicular skeletal muscle mass

  6. lower limb muscle strength

    Time frame: Baseline (Visit 1)

    lower limb muscle strength

  7. Timed Up & Go test

    Time frame: Baseline (Visit 1)

    Timed Up & Go test

Study contacts

Contact information is provided by the study sponsor or research team.

Bo-Ram Kim

CONTACT

• +82317877732

Jae-Young Lim

CONTACT

[email protected]

• +821053900373

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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