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Enrolling by Invitation

NCT Number: NCT06658821

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.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LDL557-HK capsule

Dietary Supplement

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 capsule

Dietary Supplement

Subjects will take once a day during the experimental period. one placebo capsule within 30 minutes before lunch.

Primary outcomes

  1. WOMAC

    Time frame: Baseline, Week 4, Week 8, and Week 12

    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).

Secondary outcomes

  1. KOOS

    Time frame: Baseline, Week 4, Week 8, and Week 12

    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.

  2. Lequesne's index

    Time frame: Baseline, Week 4, Week 8, and Week 12

    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.

  3. VAS

    Time frame: Baseline, Week 4, Week 8, and Week 12

    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.

  4. Quality of life (QOL) SF-36

    Time frame: Baseline, Week 4, Week 8, and Week 12

    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).

  5. Kellgren-Lawrence Grade

    Time frame: Baseline and Week 12

    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)

  6. Joint range of motion assessment

    Time frame: Baseline and Week 12

    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).

  7. Timed Up and Go Test

    Time frame: Baseline and Week 12

    The time taken to rise from a chair, walk 3 meters, turn, return, and sit down will be recorded. Unit of Measure: Seconds (s)

  8. Stair Climb Test

    Time frame: Baseline and Week 12

    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)

  9. Aerobic Capacity

    Time frame: Baseline and Week 12

    Aerobic capacity will be assessed using 6-minute walk test to evaluate endurance. Unit of Measure: Meters (m)

  10. Inflammation assessment

    Time frame: Baseline and Week 12

    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).

  11. Thigh circumference

    Time frame: Baseline and Week 12

    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.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Collaborators

  • SYNBIO TECH INC. Kaohsiung Taiwan

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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