GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease

Sponsor

University of Aarhus (Other)

Overall Status

Unknown status

CT.gov ID

NCT02245594

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease Inflammatory Bowel Disease Sleep Disturbances

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

May 1, 2015

Anticipated Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Gl motility and sleep pattern

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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