Mind/Body Medicine and IBD Flare-Up
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- gut inflammation assessed by stool Calprotectin
研究概览
简要总结
Ulcerative Colitis is an Inflammatory Bowel disease that is a life-long, relapsing disabling disorder. Current treatments for Ulcerative Colitis are not satisfactory. Most medications provide only partial relief, are not successful for at least 30% of patients, and have major negative side effects. Mounting evidence indicates that stress is one of the important triggers that activates symptoms of ulcerative colitis and therefore causes flare-up. The primary aim of this study is to see if either of two 8-week Mind-Body courses has an effect in reducing stress and affecting the course and severity of UC.
Hypotheses: Stress causes Ulcerative Colitis flare-up and stress reduction will prevent Ulcerative Colitis flare-up.
详细描述
Methods: We will enroll 100 subjects in a Phase I/IIa randomized, double-blind, placebo-controlled trial. Subjects will be assigned to one of two Mind/Body courses, each of which will be held once a week for 8 consecutive weeks. Each class will last 1.5-2 hours.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of moderately severe Ulcerative Colitis
- •Age 18-70
- •Must have inactive disease at the time of recruitment, with at least one documented disease flare-up within the past 2 years.
- •Must be on either no IBD medication or have been on a stable dose of any of the following medications for the specified amount of time: Mesalamine or Sulfasalazine for at least 6 weeks; Remicade for at least 10 weeks; Imuran or Mercaptopurine at stable and unchanged dose for at least 8 weeks.
排除标准
- •Active Ulcerative Colitis or daily rectal bleeding for 7 days
- •Taking oral steroids within 30 days of enrollment, topical agents (steroids or 5-ASA) within 14 days,immunomodulators such as Methotrexate or Imuran/6-MP and Infliximab within 90 days
- •History of colon resection
- •Antibiotics use within the previous 14 days
- •Pregnant or lactating women
- •Significant chronic disorders like severe cardiac disease (NY functional state score>3), renal disease (creatinine>3 mg/dL), pulmonary disease (shortness of breath at rest or need for oxygen use), active infection, or other organ system disease requiring medical visits > 3 times /year
结局指标
主要结局
gut inflammation assessed by stool Calprotectin
时间窗: (1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course
次要结局
- Gut oxidative tissue injury assessed by mucosal protein oxidation (protein carbonyl)((1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course)
- stress responses assessed by 24h urinary cortisol and psychological questionnaire((1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course)
- prevention of flare-up assessed by IBD-related clinical, endoscopic, and histological indices((1) initial measurement (2) within 1 month of completion of course (3) 6 months after completion of course (4) 1 year after completion of course)
研究者
Ali Keshavarzian
Dr. Ali Keshavarzian
Rush University Medical Center