Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2025-12-17 @ 2:42 AM
Study NCT ID:
NCT06459700
Status:
None
Last Update Posted:
2024-07-05 00:00:00
First Post:
2024-05-22 00:00:00
Brief Title:
Effect of Probiotic Supplements on Osteoarthritis Outcomes
Sponsor:
Lund University
Organization:
Lund University
Study Overview
Official Title:
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:
None
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProOA23
Brief Summary:
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.
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.
Detailed 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 005 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
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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None