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Probiotic Supplements in Osteoarthritis

Probiotic Supplements in Osteoarthritis

Recruiting
18 years and older
All
Phase 3

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Overview

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.

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.

Eligibility

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:

  1. Rheumatoid arthritis or other active generalized inflammatory comorbidities affecting the gastrointestinal tract (IBD, celiac disease)
  2. Performed a total knee replacement on the affected knee or the waiting list for joint replacement
  3. surgeries (such as gastric bypass) or Other concomitant injuries can override OA symptoms or interfere with physical activity.
  4. Malabsorption disorders, systemic organ failure (liver, renal, cardiac)
  5. Use corticosteroids with doses above 10 mg/day or Intra-articular injections during the previous 6 months.
  6. Recent antibiotic treatment (i.e., \<2 months before the beginning of the study).
  7. Pregnancy/breastfeeding
  8. Participants who smoked more than 10 cigarettes per day were excluded.
  9. Immunosuppressive treatment or impaired immune system
  10. Chronic or acute diarrhea
  11. Blood/plasma donation/transfusion during the 3 months of the study
  12. Non-controlled diabetes
  13. Allergy with regards to any of the study product ingredients.
  14. Post-traumatic OA (e.g., fractures), congenital hip deformities, or degenerative or non-degenerative neurological conditions can alter pain perception.

Study details
    Osteoarthritis
    Knee

NCT07364578

Beni-Suef University

1 February 2026

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