Probiotics for Inflammation in Pediatric Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in systemic inflammation - CRP
研究概览
简要总结
To examine benefits of a probiotic for youth with chronic pain and a Body Mass Index >=85th percentile.
详细描述
The purpose of the current study: (1) examine whether a 7-11 week supplement of a single-strain probiotic (Lactobascillus Plantarum, Lp299v) reduces systemic inflammation; (2) determine whether reductions in systemic inflammation will correlate with reductions in pain, disability, mood impairment and changes in mechanical pain threshold and mechanical pain sensitization; (3) Explore whether reductions in systemic inflammation will correlate with reductions in other outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female biological sex
- •13-17 years of age
- •Body Mass Index ≥85th percentile for sex and age
排除标准
- •Probiotic (or prebiotic) supplement use or antibiotic use within the past month
- •Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids
- •Patients who have had a poor response to blood draw or immunizations in the past
- •Chronic use of medications known to alter gastrointestinal function or inflammation (e.g. metformin, non-steroidal anti-inflammatory medications)
- •Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
- •Use of illicit drugs
- •Females who are pregnant or lactating
研究组 & 干预措施
Probiotic
Participants will be given the probiotic supplement Lp299v. The supplement is taken by mouth in the form of capsules. Participants will undergo a screening visit. After 7-11 weeks of taking Lp299v, they will return for their final visit. Blood will be drawn before and after the 7- 11 week intervention.
干预措施: Lactobacillus Plantarum (Dietary Supplement)
结局指标
主要结局
Change in systemic inflammation - CRP
时间窗: 7-11 weeks
Change in circulating C-Reactive Protein after 8 weeks of probiotic supplement.
次要结局
- Change in Worst Pain intensity(7-11 weeks)
研究者
Keri Hainsworth
Associate Professor
Medical College of Wisconsin