Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The current study aims to evaluate the effectiveness of adding probiotics to the standard of care in improving OA patient-related outcomes such as pain, stiffness, and physical activity.
Osteoarthritis (OA) is a severe progressive chronic arthropathy causing articular remodeling and inflammation of synovial tissue. The disease involves the entire synovial joint, including the cartilage, joint lining, and subchondral bone. OA causes pain, swelling, and stiffness, consequently hindering the patient's ability to perform their main daily activities, which often leads to social isolation and depression. Up till now, there is no cure for OA treatment options target either symptomatic relief (mainly pain) such as acetaminophen, glucosamine, chondroitin sulfate, and non-steroidal anti-inflammatory drugs (NSAIDs) or structure repair.
Probiotics are live and active microorganisms widely known as the gut's beneficial bacteria. They are taken to alter the GI flora and provide health benefits such as achieving optimal digestion and immunological function.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | OA patients will receive only standard of care |
|
| probiotic group | Experimental | OA patients will receive probiotic supplements (2 times daily) added to the standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Formula | Drug | probiotic supplements (lactobacillus, 2 times daily) added to standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | A self-administered measure used in assessing pain, stiffness, and function in OA patients | 3 months |
| Visual Analogue Scale (VAS) | A pain rating scale that represents the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." The patient marks the line according to his/her perception of their current state. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Knee Injury and Osteoarthritis Outcome Score (KOOS) | a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. | 3 months |
Not provided
Inclusion Criteria:
Patients (both sexes) aged above 18 years who met the American College of Rheumatology (ACR) clinical criteria for KOA [7] and had symptomatic OA of at least one knee (index knee).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asmaa A Elsayed | Contact | 01095727201 | asmaa.abdelfattah@pharm.sohag.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Asmaa Elsayed | Beni-Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asmaa Abdelfattah Elsayed | Recruiting | Banī Suwayf | 82511 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
outcome assessors were blinded to participant data. the researcher coded patient data before analysis
| Control | Drug | standard of care |
|
| D012216 |
| Rheumatic Diseases |