The Effect of LDL557 on Improving Degenerative Arthritis in the Elderly

NCT06658821 | Enrolling By Invitation

• 1 other identifier: CS2-24147
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthritis; Joint Pain

Outcome Measures

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).

  Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes (11)

• KOOS

  Baseline, Week 4, Week 8, and Week 12

• Lequesne's index

  Baseline, Week 4, Week 8, and Week 12

• VAS

  Baseline, Week 4, Week 8, and Week 12

• Quality of life (QOL) SF-36

  Baseline, Week 4, Week 8, and Week 12

• Kellgren-Lawrence Grade

  Baseline and Week 12

Study Arms (2)

LDL557-HK capsule

EXPERIMENTAL

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 capsule

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Capsule

Interventions

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.

LDL557-HK capsule

Placebo Capsule DIETARY_SUPPLEMENT

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

Placebo capsule

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead
• SYNBIO TECH INC. Kaohsiung Taiwan: collaborator

Study Sites (1)

Chung Shan Medical University

Taichung, Taiwan

Location

MeSH Terms

Conditions

Arthritis; Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 26, 2024
• Study Start: February 27, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

TW (1)