Precision Application of Clostridium Butyricm of Clinical Research on Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis; Knee
• Interventions: Behavioral: Western Ontario and McMaster University Osteoarthritis Index (WOMAC); Behavioral: Visual Analogue Scale (VAS); Diagnostic Test: Kellgren Lawrence Grading Scale (KL score)

• Registration Number: NCT06570408
• Lead Sponsor: China Medical University Hospital

Brief Summary

Osteoarthritis (OA) is a common joint disease worldwide. The main symptom is that the mechanical wear of the cartilage in the joint and leads to the abnormal proliferation of the surrounding bone and synovial tissue with the chronic inflammation and the narrowing of the joint cavity. The prevalence of OA is increasing due to population increasing and aging, and there are currently about 400 million OA patients in worldwide. The treatment methods of osteoarthritis are mainly divided into medicine and non-medicine therapy. The major function of medicine therapy is to reduce pain and the arthroscopic surgery (arthroscopy) is main treatment of non-medicine therapy. Thus, in this project the investigators will mainly focus on the precise application of Clostridium butyricum on OA and the investigators' previous study successfully demonstrated the therapeutic effects of Clostridium butyricum on OA animal model. Therefore, will test the clinical effects of OA patient with Clostridium butyricum treatment, and whether it is also possible to improve the symptom of OA patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-08-30
• Study Completion: 2024-02-29
• Study First Submitted: 2024-07-29
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• A. Patients aged 55 to 75 years old with degenerative arthritis, diagnosed by a physician as suitable for participation in this experiment.

B. Patients with early-stage degenerative arthritis symptoms, as interpreted by X-ray using the Kellgren Lawrence Grading Scale at grade 1 or 2, and determined by a physician to not require long-term treatment.

C. Patients with a high pain index when the knee is extended 40-70 mm.

D. Patients who feel knee pain, primarily those with a high Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index score (pain scale score >2.0 or total WOMAC scale score >12).

Exclusion Criteria

• A. Patients with a history of knee joint trauma or knee joint surgery (including arthroscopic surgery).

B. Patients who have taken steroid medication for the treatment of degenerative arthritis.

C. Patients with severe cardiovascular, cerebrovascular, rheumatic, or psychiatric diseases.

D. Patients with joint pain caused by other factors.

E. Patients with infectious diseases or acute infections (e.g., fever, localized inflammation, abscess).

F. Patients with systemic or metabolic diseases, or progressive bone degeneration caused by medication.

G. Cancer patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (Treatment)	Western Ontario and McMaster University Osteoarthritis Index (WOMAC)	-
Group A (placebo)	Visual Analogue Scale (VAS)	-
Group A (placebo)	Kellgren Lawrence Grading Scale (KL score)	-
Group B (Treatment)	Visual Analogue Scale (VAS)	-
Group B (Treatment)	Kellgren Lawrence Grading Scale (KL score)	-
Group A (placebo)	Western Ontario and McMaster University Osteoarthritis Index (WOMAC)	-

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)	Day 0, 7, 14, 30, 60, 90	used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The maxima score is 105, which have more high score mean more severe level of osteoarthritis.
Visual Analogue Scale (VAS)	Day 0, 7, 14, 30, 60, 90	one of the pain rating scales used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The minima score is 0. The maxima score is 10 for each knee. the higher score mean patient feel more pain on knee joint.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, North District, Taiwan