RecruitingPhase 3NCT07364578

Probiotic Supplements in Osteoarthritis

Evaluating the Efficacy of Probiotic Supplements on Osteoarthritis Patients

Sponsor

Beni-Suef University

Enrollment

146 participants

Start Date

Feb 15, 2025

Study Type

INTERVENTIONAL

Conditions

Osteoarthritis, Knee

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

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 Criteria14

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.