A Probiotic Intervention on Pain Hypersensitivity and Microbiota Composition in Patients With Pain-osteoarthritis: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Change from Visual analogue scale (VAS) at 6 weeks
研究概览
简要总结
Many people with symptomatic Osteoarthritis (OA) report chronic joint pain, especially if those patients are older than 50 years. In Europe OA is the most common form of chronic pain condition (34%) reported and entails a high economic and social burden for society. Probiotic treatment has been shown to promote bone metabolism, reduce pain and inflammatory responses of age-related musculoskeletal disorders, including OA. Gut microbiota has been proven to be of crucial importance in maintaining human health. However, the microbiota profile changes with aging, while the loss of microbiota diversity and the alterations in the optimal composition and quantity of beneficial microbes are believed to increase the risk of many diseases. Interestingly, emerging evidence leads to the hypothesis that alterations in the gut microbiome could also be considered as possible triggering factors in the onset of musculoskeletal disorders such as OA. We hypothesize that these patients with pain-OA will demonstrate an alteration of the gut microbiota to associated with the intensity of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind (Subject, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects will have hip or knee OA according on radiographic findings (Kellgren-Lawrence scale ≥3) and who require and eligible for chronic, daily therapy with an NSAIDs to control OA sign and symptoms. A physiatrist (physician) will establish the diagnosis of pain-OA.
排除标准
- •Psychiatric or neurological disorders, celiac disease, lactose intolerance, or allergies or other ongoing illnesses (i.e., irritable bowel syndrome, diabetes, ulcerative colitis, etc.) or recent antibiotic treatment (i.e., <3 months before the beginning of the study).
- •Participants with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
- •Participants require treatment with aspirin > 325 mg /day.
- •Participants who smoked more than 10 cigarettes per day were excluded.
- •Participants will be excluded also if they score greater than 6 points on the Beck Depression Inventory (BDI) or more than 30 points in the State Trait Anxiety Inventory (STAI), dementia and not Italian speaking due to the high level of language skills required for questionnaires and quantitative sensory testing.
- •Post-traumatic OA (e.g., fractures), congenital hip deformities, surgical interventions to the hip or knee, Legg-Calvé-Perthes disease, or degenerative or non-degenerative neurological conditions in which pain perception is altered will be excluded
研究组 & 干预措施
Experimental group
Probiotic product plus usual medical care (NSAIDs use and the promotion of a healthy lifestyle).
干预措施: Experimental group (Dietary Supplement)
Experimental group
Probiotic product plus usual medical care (NSAIDs use and the promotion of a healthy lifestyle).
干预措施: Usual medical care (Other)
Control group
Sham probiotical plus usual medical care (NSAIDs use and the promotion of a healthy lifestyle).
干预措施: Control group (Dietary Supplement)
Control group
Sham probiotical plus usual medical care (NSAIDs use and the promotion of a healthy lifestyle).
干预措施: Usual medical care (Other)
结局指标
主要结局
Change from Visual analogue scale (VAS) at 6 weeks
时间窗: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Change from Pressure Pain Thresholds (PPT) at 6 weeks
时间窗: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
PPT will be assessed bilaterally \[in the center of the anterior aspect of patella (knee) and the trochanter site (hip)\]
Change from Inflammatory cytokines at 6 weeks
时间窗: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Fasting serum concentrations of interleukin (IL)-6, tumor necrosis factor (TNF)-α, soluble IL-6 receptor (IL-6sR), soluble IL-1 receptor (IL-1sR), and C-reactive protein (CRP) were measured by enzyme-linked immunosorbent assays.
Change from Microbiota at 6 weeks
时间窗: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Microbiota composition will be identified through fecal samples for total genomic DNA extraction. The bacteria belonging to Clostridium sensu stricto, Enterobacteriaceae, Escherichia coli, Bifidobacterium, Lactobacillus and yeast were dosed using quantitative PCR approach targeted on 16S rRNA gene
次要结局
未报告次要终点
研究者
Jorge Hugo Villafañe, PhD
Researcher
Fondazione Don Carlo Gnocchi Onlus