Clinical trial NCT02245594: GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease
Official title: Gastrointestinal Motility and Sleep Disturbances in Patients With Quiescent Crohn's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn's Disease
Inflammatory Bowel Disease
Sleep Disturbances
Keywords: Gastrointestinal motility
Motility Tracking System (MTS)
Transit time
Sleep pattern
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total and segmental gastrointestinal transit time in patients suffering from CD
timeFrame: Expected average total transit time less than two days, analyzed after 2-3 days
measure: Abnormal sleep pattern in patients with ileocoecal and/or colonic CD in remission
timeFrame: Recorded during a single night, analyzed one of the two following days.
Secondary outcomes:
measure: Gastric emptying in CD patients
timeFrame: Less than 1 day, analyzed after 1-3 days
measure: Small intestinal transit time in CD patients
timeFrame: Less than 2 days, analyzed after 2-3 days
measure: Segmental colonic transit time in CD patients
timeFrame: Average less than 2 day, analyzed after 2-3 days
measure: Nocturnal basic colonic activity in patients with ileocoecal and/or colonic CD in remission and sleep disturbances
timeFrame: Recorded during one night, analyzed one of the two following days
Other outcomes:
Locations:
city: Aarhus C.
country: Denmark
facility: Aarhus University Hospital, Department of Gastroenterology and Hepatology
Study officials:
affiliation: Department of Gastroenterology and Hepatology, Aarhus University Hospital
name: Klaus Krogh, MD, Dr. Med
role: STUDY_DIRECTOR
References: