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

NCT07334210 | Recruiting DMC

• 1 other identifier: B-2502-953-301
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia

Keywords

Gut microbiota; Sarcopenia; Older adults

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Beta diversity analysis values

  Baseline(Visit 1)

• Taxa plot

  Baseline(Visit 1)

• Handgrip strength

  Screening(Visit 0)

• 6-meter walking speed

  Screening(Visit 0)

• appendicular skeletal muscle mass

  Screening(Visit 0)

Study Arms (3)

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

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

tertiary general hospital

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
• meter walk speed \<1.0 m/s
• 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

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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

oral microbiome and fecal microbiome

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Jae-Young Lim

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae-Young Lim

CONTACT

• +821053900373; drlim1@snu.ac.kr

Bo-Ram Kim

CONTACT

• +82317877732

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: June 13, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)