NCT00907790已完成不适用
Nursing Management of IBS:Improving Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Daily abdominal pain
研究概览
简要总结
The aim of this study is test the efficacy of a comprehensive self-management therapy to decrease abdominal pain/discomfort and improve quality of life in patients with irritable bowel syndrome (IBS) compared to IBS patients receiving their usual care.
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
- Single (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
- •Men and women must be: 18-70 years old, have had symptoms of Irritable Bowel Syndrome (IBS) at least 6 mo prior to their diagnosis, and have had their diagnosis for at least 6 months, and the diagnosis had to be made by a health care provider (e.g., internist, gastroenterologist, family, nurse practitioner, physician assistant).
- •In addition, the subjects must be experiencing IBS symptoms as described in the Rome-III criteria.161 That is recurrent abdominal pain or discomfort at least 3 days a mo in the last 3 mo associated with 2 or more of the following: improvement with defecation, onset associated with a change in frequency or form (appearance) of their stool.
- •Adults 50 or older must have a negative colonoscopy, sigmoidoscopy, abdominal ultrasonography, or barium enema.
- •Anyone with a "red flag" symptom (e.g., lost 10 lbs without trying, blood in stool, anemia) will be contacted for additional clarification.
排除标准
- •Participants will be excluded if they are taking the following medications: antibiotics, daily use of anticholinergics, tricyclic antidepressants, calcium-channel blockers
- •Have a medical history of abdominal surgery (except appendectomy, Caesarian section, tubal ligation, laparoscopic cholecystectomy, hysterectomy, or abdominal wall hernia repair)
- •Active organic GI disease, gluten intolerance (celiac disease), or chronic moderate to severe pain condition (e.g., low back pain, fibromyalgia)
- •Recent travel to regions with endemic parasitic diseases
- •Current mental health disorders (psychosis, bipolar disorder, current moderate to severe depressive episode, suicide attempt, drug or alcohol abuse or dependence within 2yrs)
- •Cardiac valvular disease, immune compromised immunologic disorders (e.g., autoimmune conditions)
- •Women who are pregnant, breast feeding, or planning to get pregnant in the next year
结局指标
主要结局
Daily abdominal pain
时间窗: Baseline, three and six months post randomization
IBS Quality of Life Questionnaire
时间窗: Baseline, three and six months post randomization
次要结局
- Salivary cortisol(Baseline, three and six months post randomization)
- Interleukin-10(IL-10) and Interleukin-12(IL-12)(Baseline, three and six months post randomization)
- Fecal calprotectin(Baseline, three and six months post randomization)
- Intestinal permeability (urine)(Baseline, three and six months post randomization)
- Brief Symptom Inventory(Baseline, three and six months post randomization)
- Cognitive Scale for Functional Bowel Disorders(Baseline three and six months post randomization)
- Work Productivity & Activity Impairment(Baseline, three and six months post rand)
- Daily symptoms(other GI and psychological)(Baseline, three and six months post randomization)
研究者
Monica Jarrett
Professor, Co-PI
University of Washington
研究点 (2)
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