Probiotic Supplements in Osteoarthritis
Evaluating the Efficacy of Probiotic Supplements on Osteoarthritis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Banī Suwayf, Egypt, 82511
- Asmaa Abdelfattah Elsayed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- Rheumatoid arthritis or other active generalized inflammatory comorbidities affecting the gastrointestinal tract (IBD, celiac disease)
- Performed a total knee replacement on the affected knee or the waiting list for joint replacement
- surgeries (such as gastric bypass) or Other concomitant injuries can override OA symptoms or interfere with physical activity.
- Malabsorption disorders, systemic organ failure (liver, renal, cardiac)
- Use corticosteroids with doses above 10 mg/day or Intra-articular injections during the previous 6 months.
- Recent antibiotic treatment (i.e., <2 months before the beginning of the study).
- Pregnancy/breastfeeding
- Participants who smoked more than 10 cigarettes per day were excluded.
- Immunosuppressive treatment or impaired immune system
- Chronic or acute diarrhea
- Blood/plasma donation/transfusion during the 3 months of the study
- Non-controlled diabetes
- Allergy with regards to any of the study product ingredients.
- Post-traumatic OA (e.g., fractures), congenital hip deformities, or degenerative or non-degenerative neurological conditions can alter pain perception.
Study Plan
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 |
|---|---|
|
Other: Control group
OA patients will receive only standard of care
|
standard of care
|
|
Experimental: probiotic group
OA patients will receive probiotic supplements (2 times daily) added to the standard of care.
|
probiotic supplements (lactobacillus, 2 times daily) added to standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 3 months
|
A self-administered measure used in assessing pain, stiffness, and function in OA patients
|
3 months
|
|
Visual Analogue Scale (VAS)
Time Frame: 3 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Asmaa Elsayed, Beni-Suef University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Probiotic1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.