NCT06570408

Precision Application of Clostridium Butyricm of Clinical Research on Osteoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis
• Knee

Interventions

Type	Name	Description
BEHAVIORAL	Western Ontario and McMaster University Osteoarthritis Index (WOMAC)	1\. WOMAC is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales
BEHAVIORAL	Visual Analogue Scale (VAS)	2\. VAS is one of the pain rating scales used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
DIAGNOSTIC_TEST	Kellgren Lawrence Grading Scale (KL score)	3\. KL score is the most widely used clinical tool for the radiographic diagnosis of OA.Each radiograph was assigned a grade from 0 to 4,
BEHAVIORAL	Quality of Life Questionnaires and Assessments:	4\. Quality of Life Questionnaires and Assessments: include quality of life, intestinal tract, conscious assessment of pain relief.etc.

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-08-30
• Completion: 2024-02-29
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: Taiwan