Precision Application of Clostridium Butyricm of Clinical Research on Osteoarthritis

China Medical University

Status: Completed

Conditions: Osteoarthritis; Knee

Treatments: Behavioral: Visual Analogue Scale (VAS); Behavioral: Western Ontario and McMaster University Osteoarthritis Index (WOMAC); Behavioral: Quality of Life Questionnaires and Assessments:; Diagnostic Test: Kellgren Lawrence Grading Scale (KL score)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06570408

CMUH112-REC3-047

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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83 participants in 2 patient groups, including a placebo group

Group A (placebo)

Placebo Comparator group

Treatment:

Diagnostic Test: Kellgren Lawrence Grading Scale (KL score)

Behavioral: Quality of Life Questionnaires and Assessments:

Behavioral: Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

Behavioral: Visual Analogue Scale (VAS)

Group B (Treatment)

Experimental group

Treatment:

Diagnostic Test: Kellgren Lawrence Grading Scale (KL score)

Behavioral: Quality of Life Questionnaires and Assessments:

Behavioral: Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

Behavioral: Visual Analogue Scale (VAS)