Gut bacteria patterns in people with sarcopenia and using them to help develop probiotics

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

This project will test whether gut bacteria differ between older adults with sarcopenia, age-matched older controls, and younger adults to guide development of probiotics for sarcopenia.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 20 Years to 90 Years
• Sex: All
• Sponsor: Seoul National University Bundang Hospital (Academic / other)
• Locations: 1 site (Seongnam-si, Gyeonggi-do)
• Trial ID: NCT07334210 on ClinicalTrials.gov

What this trial studies

This observational study will compare the composition of gut microbiota in three groups: older adults aged 65–90 with sarcopenia, older adult controls, and younger adult controls. Participants will provide clinical assessments and stool samples, and microbiome sequencing and bioinformatic analyses will identify differences in bacterial taxa and functional profiles. The data will be used to highlight microbial features associated with sarcopenia and to inform selection of candidate probiotic strains. No investigational treatments are given as part of the protocol; the goal is to generate foundational data for future probiotic development.

Who should consider this trial

Good fit: Primary candidates are older adults aged 65–90 who meet the 2019 AWGS criteria for sarcopenia and can provide informed consent, with additional enrollment of age-matched and younger control participants who can provide stool samples.

Not a fit: People under 65, those unable to consent, or individuals whose muscle loss is driven by acute illness or non-age-related causes may not receive direct benefit from participation.

Why it matters

Potential benefit: If successful, the findings could lead to probiotics or microbiome-based approaches that help preserve or restore muscle mass and function in older adults with sarcopenia.

How similar studies have performed: Previous observational and preclinical work has linked gut microbiota to muscle health, but probiotic treatments for sarcopenia remain largely unproven in large clinical trials.

Eligibility criteria

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.

Where this trial is running

Seongnam-si, Gyeonggi-do

• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)

Study contacts

• Principal investigator: Jae-Young Lim — Seoul National University Bundang Hospital
• Study coordinator: Jae-Young Lim

Conditions Sarcopenia; Gut microbiota; Older adults