Effect of Probiotic Supplements on Osteoarthritis Outcomes

Phase

N/A

Condition

Osteoarthritis

Knee Injuries

Treatment

Placebo supplements

Probiotic supplements

Probiotic supplements/placebo supplement

Clinical Study ID

NCT06459700

ProOA23

Ages 45-70
Female

Study 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

Inclusion Criteria:

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 3months
Able to perform walking and stair tests
No use of other supplements/food products containing probiotics and/or supplementstargeting OA symptoms (e.g., glucosamine, turmeric)
Able to write and understand Swedish.

Exclusion

Exclusion Criteria:

Rheumatoid arthritis or other active generalised inflammatory comorbiditiesaffecting the gastrointestinal tract (IBD, celiac disease)
Performed a total knee replacement on the affected knee or on waiting list for jointreplacement
Other concomitant injuries or surgeries overriding the OA knee symptoms
Other concomitant injuries or diseases where physical activity is a contraindication
Malabsorption disorders, presence of renal and/or hepatic failure
Use of corticosteroids with doses above 10 mg/day and/or Intra-articular injectionsduring 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.

Study Design

Placebo supplements

July 01, 2024

April 30, 2027

Study Description

Aim:

To investigate the effect of 6-moths probiotic supplements compared to placebo on OA related outcomes in females with diagnosed knee OA.

Design: Double-blinded randomized placebo controlled trial

Study arms: One treatment arm will receive probiotic supplement in opaque white capsules and the other treatment arm will receive identical opaque placebo capsules. The placebo product will contain maize starch powder. Study participants will take one capsule daily for six months.

Statistical analysis Main outcome: The independent T-test will be used to evaluate group differences in change in KOOS-12 scores between baseline and 6-months follow-up, given that all assumptions for parametric tests are satisfied. If assumptions are not met or if there are differences in baseline characteristics due to imbalanced randomization the Mann-Whitney U-test or regression analysis will be used as appropriate.

Secondary and explorative outcomes: The independent T-test (continuous, normal distributed data), the Mann-Whitney U-test (ordinal, non-normally distributed data) and cross-tabulations with Chi2 test (nominal data) will be used to evaluate differences in secondary and explorative outcomes between the two groups.

Estimated enrollment: 86 participants. Based on the ability to detect a 10-score difference in KOOS-12 with 80% power and α 0.05, 72 participants (36 per arm) will be needed. With an approximate drop-out rate of 20% from baseline to follow-up, 86 participants will be recruited.

Investigators: Eva Ageberg, PT, PhD, Professor in physical therapy, Lund University, Sweden (Principal investigator), Anna Cronström, physical therapist, PhD, Lund University, Sweden, Jessica Neilands, PhD, Associate Professor, Science manager, Probi AB, Lund, Sweden and Daniel Benoit, PhD, senior lecturer in Experimental Health Sciences at Lund University, Sweden.

Connect with a study center

MoReLab, Lund University
Lund, 22100
Sweden
Active - Recruiting

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