NCT03078634已完成不适用
The MANTRA Study: The Multi-disciplinary Treatment of Functional Gut Disorders Study
St Vincent's Hospital Melbourne2 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2017年3月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Proportion of subjects with global improvement in their condition.
研究概览
简要总结
Randomised controlled trial comparing standard outpatient clinic treatment with multi-disciplinary clinic treatment for functional gastrointestinal disorders. Patients will be followed up to end of clinic treatment and 12 months beyond the end of treatment. Symptoms, quality of life, costs to the healthcare system and psychological outcomes will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Functional gastrointestinal disorder as defined by Rome IV
排除标准
- •Diagnosed or suspicion of organic gastrointestinal disorder (ie Coeliac, IBD)
- •Age <18 or >80
- •Non-English speaking
- •Patient's from outside of metropolitan Melbourne who cannot attend clinic visits
- •Prominent eating disorder
- •Chronic opioid dependence
- •Medications which can explain functional gut symptoms
- •Surgery of GI tract that can explain functional gut symptoms
- •Major, non-GI, organ dysfunction
- •Pregnancy
- •Major Psychiatric disorder
结局指标
主要结局
Proportion of subjects with global improvement in their condition.
时间窗: Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first.
Global improvement in their condition is defined as a response of either "slightly better" or "much better" to the question: "Compared with before I was first seen in clinic, I feel my gut condition is now:". The question is marked on a 5-point likert scale: Much worse, slightly worse, same, slightly better, much better.
次要结局
- Proportion of subjects, with Irritable bowel syndrome or centrally mediated abdominal pain syndrome, with a 50% reduction in Irritable bowel syndrome severity scoring system (IBS-SSS)(A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.)
- Proportion of subjects with faecal incontinence who score a 50% reduction in St Mark's Incontinence score(A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.)
- Quality of life as measured by Euro-QOL EQ-5D(A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.)
- Proportion of subjects with global improvement in their condition.(A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.)
- Proportion of subjects with constipation who score a 50% reduction in Cleveland clinic constipation scoring system(A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.)
- Cost to the healthcare system(A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.)
- Psychological wellbeing as measured by hospital anxiety and depression score (HADS)(A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B)12 months after discharge.)
- Somatisation as measured by somatic symptom scale-8 (SSS-8)(A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.)
- Proportion of subjects with functional dyspepsia who score a 50% reduction in the symptom score of the Nepean dyspepsia index(A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.)
- Proportion of subjects with who answer yes to: In the past 7 days, have you had adequate relief of your gut condition? [YES/NO](A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.)
- Quality of life as measured by RAND SF-36 v1(A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.)
- Proportion of subjects with a 50% reduction in gastrointestinal symptom severity index score(A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge.)
研究者
Chamara Basnayake
Gastroenterologist
St Vincent's Hospital Melbourne
研究点 (2)
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