GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease

University of Aarhus

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT02245594

MbCrohnRemission+Symp

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

20 participants in 1 patient group

Gl motility and sleep pattern