Clinical trial NCT06570408: Precision Application of Clostridium Butyricm of Clinical Research on Osteoarthritis
Official title: Precision Application of Clostridium Butyricm of Clinical Research on Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Knee
Keywords: Clostridium butyricum
Osteoarthritis
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Grape King Bio Ltd.
First posted: 2024-08-26
Enrollment: 83
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: Day 0, 7, 14, 30, 60, 90
measure: Visual Analogue Scale (VAS)
timeFrame: Day 0, 7, 14, 30, 60, 90
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: North District
Study officials:
References: