GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease

Study Overview
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Brief Summary
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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.

Official Title
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Gastrointestinal Motility and Sleep Disturbances in Patients With Quiescent Crohn's Disease

Conditions
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Crohn's Disease, Inflammatory Bowel Disease, Sleep Disturbances

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gl motility and sleep pattern<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total and segmental gastrointestinal transit time in patients suffering from CD |  | 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 |  | Recorded during a single night, analyzed one of the two following days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying in CD patients |  | Less than 1 day, analyzed after 1-3 days | 
| Small intestinal transit time in CD patients |  | Less than 2 days, analyzed after 2-3 days | 
| Segmental colonic transit time in CD patients |  | Average less than 2 day, analyzed after 2-3 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal motility, Motility Tracking System (MTS), Transit time, Sleep pattern