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Probiotic Supplements in Osteoarthritis
RECRUITINGPhase 3Sponsored by Beni-Suef University
Actively Recruiting
PhasePhase 3
SponsorBeni-Suef University
Started2025-02-15
Est. completion2026-02-15
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07364578
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions2
ArthritisOsteoarthritis, Knee
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Actively Recruiting
PhasePhase 3
SponsorBeni-Suef University
Started2025-02-15
Est. completion2026-02-15
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07364578