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