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Active Not Recruiting NCT06459700

Effect of Probiotic Supplements on Osteoarthritis Outcomes

Conditions: Knee Osteoarthritis

Sex: Female
Ages: 45 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 86
Sponsor: Lund University

Location: MoReLab, Lund University Lund

Summary

Dysbiosis of the gut microbiota is believed to contribute to the development and progression of osteoarthritis (OA), suggesting a role for probiotics in the treatment of OA. Animal studies have shown that certain probiotic strains decrease the inflammatory responses, pain sensitization and OA progression. There are, however, few clinical studies in humans to support this. In this double-blinded randomized controlled trial we will investigate the effect of 6-months probiotic supplements compared to placebo on OA related outcomes in females with diagnosed knee OA.

Eligibility Criteria

Inclusion Criteria: 1. Females aged 45-70 years 2. Clinical diagnosis of knee OA 3. Mild to moderate knee joint pain (Visual Analog Scale (VAS) 3-7)) during the last 3 months 4. Able to perform walking and stair tests 5. No use of other supplements/food products containing probiotics and/or supplements targeting OA symptoms (e.g., glucosamine, turmeric) 6. Able to write and understand Swedish. Exclusion Criteria: 1. Rheumatoid arthritis or other active generalised inflammatory comorbidities affecting the gastrointestinal tract (IBD, celiac disease) 2. Performed a total knee replacement on the affected knee or on waiting list for joint replacement 3. Other concomitant injuries or surgeries overriding the OA knee symptoms 4. Other concomitant injuries or diseases where physical activity is a contra indication 5. Malabsorption disorders, presence of renal and/or hepatic failure 6. Use of corticosteroids with doses above 10 mg/day and/or Intra-articular injections during the previous 6 months 7. Heavy use of alcohol (\>10 standard units a week), or recreational drug use 8. BMI ≥30 Kg/m2 9. Antibiotic treatment during the previous 2 months 10. clinical depression diagnosis 11. Pregnancy/breast feeding 12. Smoking or other nicotine containing products during the previous 6months 13. Performed a gastric bypass 14. Immunosuppressive treatment or impaired immune system 15. Chronic or acute diarrhoea 16. Blood/plasma donation/transfusion during the 3months or during the study 17. Non-controlled diabetes 18. Allergy with regards to any of the study product ingredients.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06459700). StuddyBuddy aggregates publicly available trial information.