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: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 45
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
MoReLab, Lund University
RECRUITING
Lund
Contact Information
Primary
Anna Cronström, PhD
anna.cronstrom@med.lu.se
+46462224965
Backup
Eva Ageberg, PhD
eva.ageberg@med.lu.se
+46462224943
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 86
Treatments
Active_comparator: Probiotic
One arm will receive probiotic supplement in opaque white capsules, 1 each day for six months
Placebo_comparator: Placebo
One arm will receive identical opaque placebo capsules containing maize starch powder (placebo), 1 each day for six months
Related Therapeutic Areas
Sponsors
Leads: Lund University
Collaborators: Probi AB

This content was sourced from clinicaltrials.gov