Probiotic supplements for knee osteoarthritis treatment

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

This study is testing whether taking probiotic supplements can help women aged 45-70 with knee osteoarthritis feel better over six months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 45 Years to 70 Years
• Sex: Female
• Sponsor: Lund University (Academic / other)
• Locations: 1 site (Lund)
• Trial ID: NCT06459700 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of probiotic supplements on outcomes related to knee osteoarthritis in females aged 45-70. Participants will be randomly assigned to receive either a probiotic supplement or a placebo for six months. The study aims to assess changes in knee osteoarthritis symptoms using the KOOS-12 score, with statistical analyses planned to evaluate differences between the two groups. The trial will enroll approximately 86 participants to ensure sufficient power to detect meaningful differences.

Who should consider this trial

Good fit: Ideal candidates are females aged 45-70 with a clinical diagnosis of mild to moderate knee osteoarthritis.

Not a fit: Patients with rheumatoid arthritis or other inflammatory conditions affecting the gastrointestinal tract will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel, non-invasive treatment option for managing knee osteoarthritis symptoms.

How similar studies have performed: While animal studies have shown promise, there are few clinical studies in humans, making this approach relatively novel.

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.

Where this trial is running

Lund

• MoReLab, Lund University — Lund, Sweden (Recruiting)

Study contacts

• Principal investigator: Eva Ageberg — Lund University
• Study coordinator: Anna Cronström, PhD

Conditions Knee Osteoarthritis