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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Jae-Young Lim; Phone Number: • +821053900373; Email: drlim1@snu.ac.kr
• Study Contact Backup: Name: Bo-Ram Kim; Phone Number: • +82317877732

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

tertiary general hospital

Description

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

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 massDEXA: <7.0 kg/m² (men), <5.4 kg/m² (women)BIA: <7.0 kg/m² (men), <5.7 kg/m² (women); Low muscle strengthHandgrip strength: <28 kg (men), <18 kg (women) or; Low physical performance6-meter walk speed <1.0 m/s5-chair stand test ≥12 secondsShort 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alpha diversity analysis values	Alpha diversity analysis values (Rarefaction and Boxplot) of gut microbiota in each group	Baseline (visit 1)
Short Physical Performance Battery (SPPB)	Short Physical Performance Battery (SPPB) results for sarcopenia physical performance evaluation in each group	Screening(Visit 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beta diversity analysis values	Beta diversity analysis values of gut microbiota (PCoA plot)	Baseline(Visit 1)
Taxa plot	Taxa plot (Relative abundance) analysis values	Baseline(Visit 1)
Handgrip strength	Handgrip strength	Screening(Visit 0)
6-meter walking speed	6-meter walking speed	Screening(Visit 0)
appendicular skeletal muscle mass	appendicular skeletal muscle mass	Screening(Visit 0)
lower limb muscle strength	lower limb muscle strength	Baseline (Visit 1)
Timed Up & Go test	Timed Up & Go test	Baseline (Visit 1)

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Jae-Young Lim, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 31, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Sarcopenia; Older adults; Gut microbiota
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia
• Other Study ID Numbers: B-2502-953-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No