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RecruitingNCT07334210Updated Jan 12, 2026

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

An observational study in Sarcopenia, sponsored by Seoul National University Bundang Hospital. Recruiting at 1 site in South Korea. Open to participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by Seoul National University Bundang Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
150
Ages
20 Years to 90 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Sarcopenia

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Keywords

  • Gut microbiota
  • Sarcopenia
  • Older adults
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's planned enrollment of 150 is above the median of 120 across 419 observational studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

tertiary general hospital

Inclusion criteria

  1. 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

  2. Older adult control group

    • Individuals aged 65 to 90 years
    • Voluntarily agree to participate in the clinical study and sign the informed consent form

  3. 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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1. 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

  • 2. Older adult control group

    Individuals aged 65 to 90 years

  • 3. Young adult control group

    Individuals aged 20 to 50 years

06

What researchers measure

Primary outcomes

  1. Alpha diversity analysis values

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

    Time frame: Baseline (visit 1)

  2. Short Physical Performance Battery (SPPB)

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

    Time frame: Screening(Visit 0)

Secondary outcomes

  1. Beta diversity analysis values

    Beta diversity analysis values of gut microbiota (PCoA plot)

    Time frame: Baseline(Visit 1)

  2. Taxa plot

    Taxa plot (Relative abundance) analysis values

    Time frame: Baseline(Visit 1)

  3. Handgrip strength

    Handgrip strength

    Time frame: Screening(Visit 0)

  4. 6-meter walking speed

    6-meter walking speed

    Time frame: Screening(Visit 0)

  5. appendicular skeletal muscle mass

    appendicular skeletal muscle mass

    Time frame: Screening(Visit 0)

  6. lower limb muscle strength

    lower limb muscle strength

    Time frame: Baseline (Visit 1)

  7. Timed Up & Go test

    Timed Up \& Go test

    Time frame: Baseline (Visit 1)

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 13620, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07334210
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Jae-Young Lim (Principal Investigator, Seoul National University Bundang Hospital) — Principal investigator
First posted
Jan 12, 2026
Start date
Jun 13, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 12, 2026

Study contacts

Jae-Young Lim
Contact
drlim1@snu.ac.kr
• +821053900373
Bo-Ram Kim
Contact
• +82317877732
Jae-Young Lim
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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