GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02245594
• Other study ID #: MbCrohnRemission+Symp
• Status: Not yet recruiting
• Phase: Phase 0
• First received: September 8, 2014
• Last updated: September 17, 2014
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: September 2014
• Source: University of Aarhus
• Contact: Katrine O. Andersen
• Phone: 004542301641
• Email: koaaarhus[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Dyssomnias
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Parasomnias
• Sleep Disorders
• Sleep Disturbances

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Gastroenterology and Hepatology	Aarhus C.

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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.	No
Secondary	Gastric emptying in CD patients		Less than 1 day, analyzed after 1-3 days	No
Secondary	Small intestinal transit time in CD patients		Less than 2 days, analyzed after 2-3 days	No
Secondary	Segmental colonic transit time in CD patients		Average less than 2 day, analyzed after 2-3 days	No
Secondary	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	No