GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C., Denmark, 8000
    • Aarhus University Hospital, Department of Gastroenterology and Hepatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with quiescent Crohn's disease who still have gastrointestinal complaints.Found in the out-patient clinic at Department V (Gastroenterology and Hepatology).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Gl motility and sleep pattern

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Director: Klaus Krogh, MD, Dr. Med, Department of Gastroenterology and Hepatology, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: September 8, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Estimate): September 19, 2014
• Last Update Submitted That Met QC Criteria: September 17, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Sleep pattern; Transit time; Gastrointestinal motility; Motility Tracking System (MTS)
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Nervous System Diseases; Sleep Wake Disorders; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Dyssomnias; Parasomnias; Crohn Disease
• Other Study ID Numbers: MbCrohnRemission+Symp