RecruitingNot ApplicableNCT06459700

Effect of Probiotic Supplements on Osteoarthritis Outcomes

Effect of 6 Months Probiotic Supplement on Pain, Function, Quality of Life and Inflammation in Females With Knee Osteoarthritis: A Double-blinded Randomized Placebo-controlled Trial

Sponsor

Lund University

Enrollment

86 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis

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

Sex: FEMALEMin Age: 45 YearsMax Age: 70 Years

Inclusion Criteria6

Females aged 45-70 years
Clinical diagnosis of knee OA
Mild to moderate knee joint pain (Visual Analog Scale (VAS) 3-7)) during the last 3 months
Able to perform walking and stair tests
No use of other supplements/food products containing probiotics and/or supplements targeting OA symptoms (e.g., glucosamine, turmeric)
Able to write and understand Swedish.

Exclusion Criteria18

Rheumatoid arthritis or other active generalised inflammatory comorbidities affecting the gastrointestinal tract (IBD, celiac disease)
Performed a total knee replacement on the affected knee or on waiting list for joint replacement
Other concomitant injuries or surgeries overriding the OA knee symptoms
Other concomitant injuries or diseases where physical activity is a contra indication
Malabsorption disorders, presence of renal and/or hepatic failure
Use of corticosteroids with doses above 10 mg/day and/or Intra-articular injections during the previous 6 months
Heavy use of alcohol (>10 standard units a week), or recreational drug use
BMI ≥30 Kg/m2
Antibiotic treatment during the previous 2 months
clinical depression diagnosis
Pregnancy/breast feeding
Smoking or other nicotine containing products during the previous 6months
Performed a gastric bypass
Immunosuppressive treatment or impaired immune system
Chronic or acute diarrhoea
Blood/plasma donation/transfusion during the 3months or during the study
Non-controlled diabetes
Allergy with regards to any of the study product ingredients.