Crohn's DiseaseNCT02245594
GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease
An observational study of Crohn's Disease and Inflammatory Bowel Disease, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Crohn's Disease, Inflammatory Bowel Disease, Sleep Disturbances
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Gastroenterology and Hepatology
Aarhus C, 8000
Katrine O. Andersen, 004542301641, koaaarhus@gmail.com
About this study
Official title: Gastrointestinal Motility and Sleep Disturbances in Patients With Quiescent Crohn's Disease
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:
Read more
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.
- Keywords
- Gastrointestinal motility, Motility Tracking System (MTS), Transit time, Sleep pattern
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gl motility and sleep pattern | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and segmental gastrointestinal transit time in patients suffering from CD
Measured: 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
Measured: Recorded during a single night, analyzed one of the two following days.
Secondary outcomes (4)
Gastric emptying in CD patients
Measured: Less than 1 day, analyzed after 1-3 days
Small intestinal transit time in CD patients
Measured: Less than 2 days, analyzed after 2-3 days
Segmental colonic transit time in CD patients
Measured: 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
Measured: Recorded during one night, analyzed one of the two following days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaus Krogh, MD, Dr. Med, Study director, Department of Gastroenterology and Hepatology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245594
- Sponsor's protocol ID
- MbCrohnRemission+Symp
- Status last verified
- Sep 2014
- First submitted
- 8 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Motility and Sleep Disturbances in Patients With Quiescent Crohn's Disease
- ClinicalTrials.gov ID
- NCT02245594
- Acronym / sponsor ID
- MbCrohnRemission+Symp
- Keywords
- Gastrointestinal motility, Motility Tracking System (MTS), Transit time, Sleep pattern
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gl motility and sleep pattern | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (14 listed)
- Stricturizing CD
- Obvious stenotic symptoms
- Previous major gastrointestinal surgery
- Diagnosis of other gastrointestinal diseases affecting motility (ex. Coeliac disease)
- Medication altering gastrointestinal motility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total and segmental gastrointestinal transit time in patients suffering from CD
Time frame: 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
Time frame: Recorded during a single night, analyzed one of the two following days.
4 secondary outcomes
Gastric emptying in CD patients
Time frame: Less than 1 day, analyzed after 1-3 days
Small intestinal transit time in CD patients
Time frame: Less than 2 days, analyzed after 2-3 days
Segmental colonic transit time in CD patients
Time frame: 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
Time frame: Recorded during one night, analyzed one of the two following days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Krogh, MD, Dr. Med study director
Department of Gastroenterology and Hepatology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Inflammatory Bowel Disease, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrine O. Andersen (004542301641, koaaarhus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total and segmental gastrointestinal transit time in patients suffering from CD (time frame: Expected average total transit time less than two days, analyzed after 2-3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.