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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Knee injury and Osteoarthritis Outcome Score (KOOS)-12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Rheumatoid arthritis or other active generalised inflammatory comorbidities affecting the gastrointestinal tract (IBD, celiac disease)
- •Performed a total knee replacement on the affected knee or on waiting list for joint replacement
- •Other concomitant injuries or surgeries overriding the OA knee symptoms
- •Other concomitant injuries or diseases where physical activity is a contra indication
- •Malabsorption disorders, presence of renal and/or hepatic failure
- •Use of corticosteroids with doses above 10 mg/day and/or Intra-articular injections during 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.
研究组 & 干预措施
Probiotic
One arm will receive probiotic supplement in opaque white capsules, 1 each day for six months
干预措施: Probiotic supplements (Dietary Supplement)
Placebo
One arm will receive identical opaque placebo capsules containing maize starch powder (placebo), 1 each day for six months
干预措施: Placebo supplements (Dietary Supplement)
结局指标
主要结局
Knee injury and Osteoarthritis Outcome Score (KOOS)-12
时间窗: 6 months
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.
次要结局
- 40m fast paced walk test(6 months)
- Work Productivity and Activity Impairment questionnaire (WPAI)(3 to 6 months)
- Patient Acceptable Symptom State (PASS)(3 to 6 months)
- 3 minute walk test(6 months)
- Knee injury and Osteoarthritis Outcome Score (separate subscale score)(3 to 6 months)
- Pain-relieving medication intake(3 to 6 months)
- 30 seconds sit to stand test(6 months)
- Stair climb test(6 months)
- Visual Analogue Scale (VAS)(3 to 6 months)
- Wish for surgery(3 to 6 months)
- Molecular biomarkers for cartilage degeneration and inflammation.(6 months)