GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease

• Conditions: Inflammatory Bowel Disease; Sleep Disturbances; Crohn's Disease

• Registration Number: NCT02245594
• Lead Sponsor: University of Aarhus

Brief Summary

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).

1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal gastric emptying and small intestinal transit (secondary endpoints).

2. 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.

3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns.

4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or colonic CD in remission and sleep disturbances.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-09
• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-17
• Last Update Submitted: 2014-09-17
• Study First Posted: 2014-09-19
• Last Update Posted: 2014-09-19
• Study Start: 2014-10
• Primary Completion: 2015-05
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Aarhus University Hospital, Department of Gastroenterology and Hepatology; 🇩🇰 Aarhus C., Denmark