ClinicalTrials.gg
Enrolling by invitationNCT06658821Updated Aug 17, 2026

The Effect of LDL557 on Improving Degenerative Arthritis in the Elderly

An interventional study of LDL557-HK capsule and Placebo Capsule in Arthritis and Joint Pain, sponsored by Chung Shan Medical University. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Chung Shan Medical University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Arthritis
  • Joint Pain
03

In context

Arthritis

843 studies on the registry are indexed under Arthritis; 118 are open to participants now.

This study's planned enrollment of 100 is close to the median of 97 across 599 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Chung Shan Medical University is the lead sponsor of 125 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    Placebo capsule

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

    Dietary Supplement: Placebo Capsule

Interventions

  • Dietary supplementLDL557-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.

  • Dietary supplementPlacebo Capsule

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

06

What researchers measure

Primary outcomes

  1. 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).

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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).

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

  5. 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)

    Time frame: Baseline and Week 12

  6. 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).

    Time frame: Baseline and Week 12

  7. 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)

    Time frame: Baseline and Week 12

  8. 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)

    Time frame: Baseline and Week 12

  9. Aerobic Capacity

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

    Time frame: Baseline and Week 12

  10. 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).

    Time frame: Baseline and Week 12

  11. 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.

    Time frame: Baseline and Week 12

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Jun 2027, 28 months after the start.

Of 134 non-industry interventional studies with no phase under Arthritis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 57. This study's planned 28 months is close to that.

Counting every sponsor, half of 167 studies reached it within 31 months; a quarter within 13 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2024
First posted
Oct 26, 2024
StartActual
Feb 27, 2025
Primary completionEst.
Jun 30, 2027
CompletionEst.
Aug 30, 2027
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06658821
Collaborators
SYNBIO TECH INC. Kaohsiung Taiwan
Responsible party
Sponsor
First posted
Oct 26, 2024
Start date
Feb 27, 2025
Primary completion
Jun 30, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Aug 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion