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GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease

NCT02245594·1 site·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Katrine O. Andersen
CONTACT
004542301641 koaaarhus@gmail.com

Lead

University of Aarhus

Age

18–85

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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)

You may not be if

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

The record

StatusUnknown

PhaseNo phase

Taking part20

StartedOct 2014

UpdatedSep 19, 2014

Conditions

Crohn's Disease Inflammatory Bowel Disease Sleep Disturbances

Where1

Aarhus University Hospital, Department of Gastroenterology and Hepatology
Aarhus C, Denmark