Gastrointestinal Motility and Sleep Disturbances in Patients With Quiescent Crohn's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total and segmental gastrointestinal transit time in patients suffering from CD
研究概览
简要总结
In this study we would like to clarify the effect of long lasting Crohn's Disease on motility of the gastrointestinal system in patient and the effect regarding sleep disturbances. This will be done with a newly developed 3D-Motility-and-Transit-detector (Motilis Medica, Schweiz) and the well known polysomnographic equipment.
Our hypothesises are:
Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal colonic transit (primary endpoint).
- Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal gastric emptying and small intestinal transit (secondary endpoints).
- Total and segmental transit times found in patients with CD will be compared with corresponding transit times in healthy volunteers found in a previous study.
- Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns.
- Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or colonic CD in remission and sleep disturbances.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CD based on accepted endoscopic and histological criteria (according to ECCO guidelines (17) )
- •Age ≥18 years
- •A minimum disease duration of five years
- •Remission defined by Faecal calprotectin < 100 and CRP level within normal values for a minimum of 1 month
- •Baseline values:
- •CRP normal
- •Faecal calprotectin < 100
- •Ileocoecal and/or colic localization of disease (Montreal phenotype classification)
- •One or more IBS-like-symptoms (abdominal pain and discomfort, diarrhea, constipation)
排除标准
- •Stricturizing CD
- •Obvious stenotic symptoms
- •Previous major gastrointestinal surgery
- •Diagnosis of other gastrointestinal diseases affecting motility (ex. Coeliac disease)
- •Medication altering gastrointestinal motility
- •Hepatobiliary disease (PSC)
- •Diabetes Mellitus
- •Metabolic disorder
- •Bacterial overgrowth (hydrogen breath test)
- •Planned MR scan in the four weeks following capsule intake (safety precaution)
- •Abdominal diameter > 140 cm
- •Implanted electronic devices (pacemaker, ICD, etc.)
- •Diagnosed sleep disorder
- •Pregnancy and breast feeding
结局指标
主要结局
Total and segmental gastrointestinal transit time in patients suffering from CD
时间窗: Expected average total transit time less than two days, analyzed after 2-3 days
Abnormal sleep pattern in patients with ileocoecal and/or colonic CD in remission
时间窗: Recorded during a single night, analyzed one of the two following days.
次要结局
- Nocturnal basic colonic activity in patients with ileocoecal and/or colonic CD in remission and sleep disturbances(Recorded during one night, analyzed one of the two following days)
- Gastric emptying in CD patients(Less than 1 day, analyzed after 1-3 days)
- Segmental colonic transit time in CD patients(Average less than 2 day, analyzed after 2-3 days)
- Small intestinal transit time in CD patients(Less than 2 days, analyzed after 2-3 days)