Effect of Probiotic Supplements on Osteoarthritis Outcomes
NCT Number: NCT06459700
Acronym: ProOA23
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Osteoarthritis
Interventions: DIETARY_SUPPLEMENT: Probiotic supplements|DIETARY_SUPPLEMENT: Placebo supplements
Sponsor: Lund University
Collaborators: Probi AB
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 86
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07-01
Completion Date: 2027-04-30
Locations: MoReLab, Lund University, Lund, 22100, Sweden

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.

Primary Outcome Measures: Knee injury and Osteoarthritis Outcome Score (KOOS)-12, Change in the KOOS-12 (total score) from baseline to 6 months in the probiotic group compared with the placebo group. The KOOS-12 is scored from 1-100 (worst-best) scale., 6 months
Secondary Outcome Measures: Knee injury and Osteoarthritis Outcome Score (separate subscale score), Comparison of the probiotic group with the placebo group in terms of changes from baseline to 3-month and 6-month follow-up in Scores on the separate subscales (pain, symptoms, activity of daily living, sport/recreation and knee-related quality of life) from the full KOOS questionnaire. The KOOS is scored from 1-100 (worst-best) scale., 3 to 6 months|Visual Analogue Scale (VAS), Comparison of the probiotic group with the placebo group in terms of changes from baseline to 3-month and 6-month follow-up in VAS scores (pain severity), assessed on an ordinal scale from 0 to 10 where 0 indicates no pain and 10 worst possible pain the last week, 3 to 6 months|Work Productivity and Activity Impairment questionnaire (WPAI), Comparison of the probiotic group with the placebo group in terms of changes from baseline to 3-month and 6-month follow-up in WPAI. The WPAI questionnaire includes 6 questions regarding employee's absenteeism, reduced job performance, work productivity loss, and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes., 3 to 6 months|Patient Acceptable Symptom State (PASS), Comparison of the probiotic group with the placebo group in terms of changes from baseline to 3-month and 6-month follow-up in PASS. The PASS involves a question regarding if the patient is satisfied with their current knee function with to response options (yes/no), 3 to 6 months|Pain-relieving medication intake, Comparison of the probiotic group with the placebo group in terms of changes from baseline to 3-month and 6-month follow-up in pain-relieving medication intake. Here the patients reports the type and dosage of any medication, 3 to 6 months|Wish for surgery, Comparison of the probiotic group with the placebo group in terms of changes from baseline to 3-month and 6-month follow-up in wish for surgery. The patients are asked if they wish to undergo surgery due to their knee problems (yes/no)., 3 to 6 months|40m fast paced walk test, Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up in 40m fast paced walk test, assessed as time taken to walk 4x10 meter as fast as possible, 6 months|30 seconds sit to stand test, Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up in the 30 seconds sit to stand test, assessed by the number of repetitions of sitting to standing from a chair during a period of 30 second., 6 months|Stair climb test, Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up in the stair climb test, assessed as time taken to ascend and descend a flight of 5 stairs., 6 months|3 minute walk test, Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up in the 3 minute walk test, assessed as distance walked during 3 minutes on a treadmill., 6 months|Molecular biomarkers for cartilage degeneration and inflammation., Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up in molecular biomarkers for cartilage degeneration and inflammation., 6 months
Other Outcome Measures: Kinematics assessed with 3D motion analysis, Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up in Kinematics (joint angles in degrees) during the functional tasks, 6 months|Kinetics assessed with 3D motion analysis and force plates, Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up in kinetics (joint moments (newton meter)) during the functional tasks., 6 months|Intestinal barrier integrity, Comparison of the probiotic group with the placebo group in terms of changes from baseline and 6-month follow-up a molecular biomarker for intestinal barrier integrity (Zonulin), 6 months