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A Human Study to Evaluate the Efficacy of CKDB-344 for Improving Muscle Strength and Physical Function

A 12-week, Randomized, Double-blind, Placebo-controlled Human Study to Evaluate the Safety and Efficacy of the Probiotic Combination of L. reuteri CKDB010 and B. longum NBM7-1 (CKDB-344) for Improving Muscle Strength and Physical Function

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0012241
Enrollment
100
Registered
2026-07-07
Start date
2026-06-19
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Test Product: Capsules containing CKDB-344 Comparator Product: Placebo capsules identical in appearance and dosage form to the investigational product and not containing CKDB-344

Sponsors

Woosuk University Korean Medicine Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects who voluntarily provided written informed consent after receiving a full explanation of the study 2) Male and female adults aged 50 to 85 years at the time of providing written informed consent 3) Subjects with a body mass index (BMI) =18.5 kg/m² and 9

Exclusion criteria

Exclusion criteria: 1) Subjects with a history of fragility hip fracture 2) Subjects with any of the following conditions, medical histories, or surgical histories: musculoskeletal disorders, neurological disorders, uncontrolled hypertension, uncontrolled diabetes mellitus, taking medications for the treatment of psychiatric disorders, gastrointestinal disorders that may affect the ingestion or absorption of the investigational product, etc 3) Heavy smokers 4) Subjects with hypersensitivity to any component of the investigational product or a history of allergy that, in the investigator's judgment, makes participation in the study inappropriate 5) Subjects who participated in another clinical study and received an investigational product, investigational food, investigational medical device within 3 months prior to screening 6) Subjects who, in the investigator's judgment, are considered unsuitable for participation in the study for any other reason 7) Pregnant or lactating women 8) Women of childbearing potential and men who are unable or unwilling to use appropriate methods of contraception during the study period

Design outcomes

Primary

MeasureTime frame
Handgrip strength

Secondary

MeasureTime frame
SPPB (Short Physical Performance Battery);Body Fat Mass;Fat-Free Mass;Appendicular Skeletal Muscle Mass;Appendicular Skeletal Muscle Mass/Height^2, Appendicular Skeletal Muscle Mass/Weight, Appendicular Skeletal Muscle Mass/Body Mass Index;Isokinetic muscle strength;Isokinetic Muscle Endurance;Isokinetic Muscle Power

Countries

Korea, Republic of

Contacts

Public ContactSoojung Park

Woosuk University Korean Medicine Medical Center

taorgi@hanmail.net+82-63-220-8676

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 23, 2026