Precision Application of Clostridium Butyricm of Clinical Research on Osteoarthritis

August 22, 2024 updated by: China Medical University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • North District
      • Taichung, North District, Taiwan, 404327
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group A (placebo)
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.
Experimental: Group B (Treatment)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time Frame: 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.
Day 0, 7, 14, 30, 60, 90
Visual Analogue Scale (VAS)
Time Frame: 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.
Day 0, 7, 14, 30, 60, 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Collaborators

Grape King Bio Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH112-REC3-047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe