Fecal Microbiota Transplantation for Patients With Chronic Widespread Pain: A Pilot Prospective Single-arm Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in self-reported pain severity
研究概览
简要总结
This study aims to explore the effect of Fecal Microbiota Transplantation (FMT) on the clinical symptomatology in Chronic Widespread Pain (CWP), to assess the acceptability, tolerability, and safety of FMT in patients with CWP, as well as explore the effect of FMT on the gut microbiome diversity in CWP. The investigators hypothesize that fecal microbiota transplantation will reduce pain intensity in patients with CWP, is acceptable, safe, and tolerable in patients with CWP, and will achieve change of gut microbiome diversity after FMT treatment.
详细描述
In this proposed proof-of-concept pilot study, the investigators capitalize an establish chronic pain cohort to explore the effect of FMT in improving the pain symptomology in patients with CWP. This will be a 12-week single-arm prospective interventional study, all study subjects will receive 3 FMT infusions (N =20).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged ≥ 18 with diagnosis CWP; A modified version of the London Fibromyalgia Epidemiology Study Screening Questionnaire (LFESSQ) will be used to screen for the presence of CWP.
排除标准
- •Patients with fibromyalgia, a subgroup with complex neurobiological, behavioural and psychological factors on its pathogenesis, will be excluded.[8] This will be based on The American College of Rheumatology 2010 when subjects with CWP but with a widespread pain index (WPI) of ≥ 7 and a symptom severity scale (SSS) score of ≥ 5 or a WPI between 3 and 6 and an SSS score of ≥
- •Patients have a history of inflammatory bowel disease or gastrointestinal malignancy
- •Patients have previous abdominal surgery (other than cholecystectomy or appendectomy)
- •Patients have depression defined by having a Patient Health Questionnaire-9 (PHQ-9) score > 15
- •Patients have anxiety defined by having a Generalized Anxiety Disorder 7 (GAD7) score > 10
- •Patients have active infection at the time of inclusion
- •Patients have used antibiotic therapy or anti-inflammatory drugs within the past 7 days
- •Patients have any other organic causes that can explain the symptoms of CWP
- •Current pregnancy
- •Confirmed current active malignancy or cancers
- •Pregnancy test negative for all female patients of child-bearing potential (except postmenopausal patients and sterilized patients).
结局指标
主要结局
Changes in self-reported pain severity
时间窗: Study week 0 , 6 , 12
Pain severity will be measured by Brief Pain Inventory (BPI), which consists of 4-item severity and 7-item interference subscale scores (Score range 0-10)
次要结局
- Sociodemographic data(At baseline, Study week 0)
- Changes in objectively measured pain pressure threshold(Study week 0 , 6 , 12)
- Changes in comorbid psychopathology (anxiety symptoms)(Study week 0 , 6 , 12)
- Changes in comorbid psychopathology (depressive symptoms)(Study week 0 , 6 , 12)
- Changes in health-related quality of life(Study week 0 , 6 , 12)
- Safety and tolerability of supplementation of FMT(through study completion, an average of 1 year)
- Changes in Alpha diversity index of gut microbiota(Study week 0 , 6 , 12)
研究者
Regina Wing Shan Sit
Prof. Regina Wing Shan SIT
Chinese University of Hong Kong