NCT06459700

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Lund University · Academic / Other
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Aim: To investigate the effect of 6-months 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-point difference in KOOS-12 with 80% power and α 0.05, 70 participants (35 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 and Jessica Neilands, PhD, Associate Professor, Science manager, Probi AB, Lund, Sweden.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic supplements	See arm/group description
DIETARY_SUPPLEMENT	Placebo supplements	See arm/group description

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2024-06-14
• Last updated: 2026-04-03

Locations

1 site across 1 country: Sweden