The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Change in erythrocyte sedimentation rate (ESR)
研究概览
简要总结
The purpose of this study is to determine whether probiotics in addition to standard of care (SOC) can improve immunological markers following treatment for prosthetic joint infection (PJI). The study aims to determine whether probiotics in addition to SOC decrease immunological markers following treatment for PJI, improve medical and surgical complications and mortality in patients with PJI, and lead to improved gastrointestinal (GI)-specific patient reported outcomes measures (PROMs) in patients with PJI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 18-90 years of age.
- •Diagnosis of PJI based upon Musculoskeletal Infection Society (MSIS) criteria
- •Planned treatment with surgical debridement, antibiotics, implant retention (DAIR), single- and two-stage revision total joint arthroplasty (TJA) for PJI with an anticipated plan for eventual discontinuation of oral/IV antibiotics.
- •Patients with prior PJI in the same joint that has recurred.
- •Patients who understand the benefits and risks associated with taking a probiotic and are willing and able to provide informed consent.
排除标准
- •Fungal PJI.
- •Inflammatory bowel disease, diverticulitis, history of intestinal surgery, or gastrointestinal issue where there is concern for gut integrity.
- •Severe acute gastrointestinal diseases (active bowel leak, acute colitis, acute pancreatitis).
- •Active endocarditis.
- •History of pancreatitis
- •History of intolerance to probiotics.
- •Patients that are pregnant or lactating.
- •Immunocompromised patients and patients with immunosuppressive conditions (uncontrolled HIV, chemotherapy for cancer treatment, stem cell transplantation, immunosuppressive medications for solid organ transplant, systematic corticosteroid use, immunosuppressive medications for autoimmune dysfunction, and neonates).
- •Patients who are critically ill.
- •Revision TJA for aseptic reasons.
研究组 & 干预措施
Probiotic supplementation + Standard of care
Patients will receive their first dose of the probiotic within 48 hours of starting post-operative antibiotic treatment. The probiotic is continued for the initial 6 weeks of antibiotic treatment in addition to standard of care (SOC).
干预措施: Culturelle Digestive Daily Probiotic Capsule (Dietary Supplement)
Standard of care alone
Patients do not receive any additional treatment and undergo SOC treatment.
结局指标
主要结局
Change in erythrocyte sedimentation rate (ESR)
时间窗: Baseline, 6 weeks post-antibiotic therapy
Change in concentration of C-reactive protein (CRP)
时间窗: Baseline, 6 weeks post-antibiotic therapy
Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health
时间窗: Baseline, 6 weeks post-antibiotic therapy
The PROMIS Global Health measure consists of 10 items designed to assess an individual's overall health status, encompassing physical, mental, and social well-being. Each item is scored on a Likert scale of 1-5. Scores are reported on a T-score metric, with a mean of 50 and a standard deviation of 10, meaning a score of 50 represents the average for the reference population. Higher scores indicate better health.
Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR)
时间窗: Baseline, 6 weeks post-antibiotic therapy
HOOS-JR contains 6 items from the original HOOS survey. Items are coded from 0 to 4, none to extreme, respectively. HOOS, JR is scored by summing the raw response (range 0-24) and then converting it to an interval score. The interval score ranges from 0-100, where 0 represents total hip disability and 100 represents perfect hip health.
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)
时间窗: Baseline, 6 weeks post-antibiotic therapy
KOOS-JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
次要结局
- Number of participants with medical complications from prosthetic joint infection (PJI)(12 months post-surgery)
- Number of participants with surgical complications from PJI(12 months post-surgery)
- Mortality from PJI(12 months post-surgery)
- Digestion-associated Quality of Life Questionnaire (DQLQ)(12 months post-surgery)
- The Short Health Scale for GI symptoms (SHS-GI)(12 months post-surgery)