The Effect of LDL557 on Improving Degenerative Arthritis in the Elderly

This project is to conduct a clinical trial of SYNBIO TECH INC.'s LDL557 capsule for joint protection. To understand the improvement of joint discomfort and inflammation after supplementation, we hope to provide an updated choice for modern people's joint protection.

Study Overview

• Status: Enrolling by invitation
• Conditions: Arthritis; Joint Pain
• Intervention / Treatment: Dietary supplement: LDL557-HK capsule; Dietary supplement: Placebo Capsule

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• BMI 18-40 kg/m2;
• Those with early stage degenerative arthritis symptoms judged by X-ray to be Kellgren-Lawrence Grading Scale level 1 or 2, and the physician determines that long-term treatment is not needed or WOMAC score>2.0 or WOMAC total scale score>12 or VAS score ≦6.

Exclusion Criteria:

• Smoking
• alcoholism
• diabetes
• breastfeeding women and pregnant women.
• Those consuming dietary supplements were excluded.
• Those who use non-steroidal anti-inflammatory analgesics and those who have had joint surgery.
• Rheumatoid arthritis.
• Those who have had joint injections within 6 months.
• Those with cardiovascular and cerebrovascular, rheumatoid or mental diseases.
• Patients undergoing cancer treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LDL557-HK capsule; Subjects will take one capsule of the experimental group(LDL557-HK capsule) within 30 minutes before lunch during the experimental period.	Dietary supplement: LDL557-HK capsule; Subjects will take once a day during the experimental period. one LDL557-HK capsule(Heat-killed Lactobacillus delbrueckii subsp. lactis LDL557 1x10^10cell) within 30 minutes before lunch.
Placebo Comparator: Placebo capsule; Subjects will take one placebo capsule within 30 minutes before lunch during the experimental period.	Dietary supplement: Placebo Capsule; Subjects will take once a day during the experimental period. one placebo capsule within 30 minutes before lunch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).	Baseline, Week 4, Week 8, and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS	The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire for patients with knee injuries or osteoarthritis. It helps measure their pain, symptoms, daily activities, sports ability, and quality of life. The scores are converted to 0-100 for each category. A higher score means worse knee problems.	Baseline, Week 4, Week 8, and Week 12
Lequesne's index	The Lequesne's Index is a questionnaire designed to evaluate the severity of osteoarthritis in the hip or knee. It assesses pain or discomfort during activities, the ability to walk certain distances, and difficulties in daily activities. The total score ranges from 0 to 24, with higher scores indicating more severe symptoms and greater impact on mobility and quality of life.	Baseline, Week 4, Week 8, and Week 12
VAS	Using the Visual Analogue Scale (VAS) to measure knee pain. Patients rate their pain on a straight line, where 0 means no pain and 10 means the worst pain imaginable. The patient marks a point on the line that represents their pain level, and the score is measured in centimeters or millimeters.	Baseline, Week 4, Week 8, and Week 12
Quality of life (QOL) SF-36	The SF-36 questionnaire is widely used to measure perceived health-related quality of life (HRQOL) and daily functioning. It consists of 36 items, which are summarized into two main domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).	Baseline, Week 4, Week 8, and Week 12
Kellgren-Lawrence Grade	The Kellgren-Lawrence (KL) grading system is a widely used method for classifying the severity of osteoarthritis (OA) based on radiographic findings. It consists of five grades, ranging from 0 to 4 (Normal, Doubtful, Mild, Moderate, Severe)	Baseline and Week 12
Joint range of motion assessment	Joint range of motion (ROM) assessment evaluates the movement capacity of a joint, focusing on its flexibility and mobility. For the extensor and flexor muscle groups, the assessment measures the degree of joint extension (straightening) and flexion (bending).	Baseline and Week 12
Timed Up and Go Test	The time taken to rise from a chair, walk 3 meters, turn, return, and sit down will be recorded. Unit of Measure: Seconds (s)	Baseline and Week 12
Stair Climb Test	Participants will be asked to ascend and descend a standardized flight of stairs, and the time required will be recorded. Unit of Measure: Seconds (s)	Baseline and Week 12
Aerobic Capacity	Aerobic capacity will be assessed using 6-minute walk test to evaluate endurance. Unit of Measure: Meters (m)	Baseline and Week 12
Inflammation assessment	Using the ELISA method, measure the serum levels of inflammatory markers, including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), prostaglandin E2 (PGE2), tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), interleukin-10 (IL-10), matrix metalloproteinase-3 (MMP-3), and matrix metalloproteinase-13 (MMP-13).	Baseline and Week 12
Thigh circumference	Wrap a flexible measuring tape around the thickest part of the thigh, typically mid-way between the hip and knee. Record the measurement in centimeters or inches.	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Collaborators: SYNBIO TECH INC. Kaohsiung Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Arthritis; Arthralgia
• Other Study ID Numbers: CS2-24147

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No