Inflammatory Bowel DiseaseEMSIBDNCT02478944
Esophageal Motility Disease Screening in Patient With Suspicion or Diagnosis of IBD
A study testing Manometry in people with Inflammatory Bowel Disease, run by University Hospital Erlangen at 1 site in Germany.
Trial summary
Aims: Prospective evaluation of patients with a suspicion or diagnosis of Inflammatory bowel disease (IBD) to evaluate osophageal motility before and during therapy Material and methods: The investigators prospectively perform manometry in patients with or with symptoms consistent with IBD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Manometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Jan 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inflammatory bowel disease
- Suspicion of inflammatory bowel disease
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Francesco Vitali, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Erlangen Nuremberg
Erlangen, Bavaria, 91054
About this study
Aims: Prospective evaluation of patients with a suspicion or diagnosis of Inflammatory bowel disease (IBD) to evaluate osophageal motility before and during therapy
Material and methods: The investigators prospectively perform manometry in patients with or with symptoms consistent with IBD. The investigators evaluate esophageal motility with high resolution manometry before, during and after IBD therapy. Clinical data are also collected to find possible correlations. The study do not modify the planned IBD therapy, but observe motility findings.
Read the detailed description
Oesophageal motility is measured with the high resolution manometry in order to detect pathologic peristaltic amplitude values among patient before and after therapy (mesalazine, steroids, biologicals) compared to the standard values detected among the normal population. Diagnosic intervention like oesophagoduodenoscopy, colonoscopy and stenosis ballon dilation are allowed as are part of the IBD therapy and follow up.
No other interventions are administered to participants during this study.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Manometry
- Keywords
- Inflammatory bowel disease, Manometry
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ManometryDevice
Flexible tube catheter pressure measurement of oesophageal contractions. Measurement without any sedation, transnasal
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory bowel disease | Experimental | Patients with Crohn's disease and ulcerative colitis undergoing manometry Receives: Device: Manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manometry finding (peristaltic amplitude values mmHG) compared to normal population findings
Measured: 1 year
Correlation with gastrointestinal symptoms to manometry findings (peristaltic amplitude values)
Measured: 1 year
Secondary outcomes (1)
Manometry findings (peristaltic amplitude values, mmHG) during therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Vitali, University Hospital Erlangen
- Investigators
- Heinz Albrecht, MD, Study director, UK Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478944
- Sponsor's protocol ID
- Gastrolabor-IBD UKE
- Acronym
- EMSIBD
- Status last verified
- Jun 2016
- First submitted
- 5 Nov 2014
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Motility Disease Screening in Patient With Suspicion or Diagnosis of IBD
- ClinicalTrials.gov ID
- NCT02478944
- Acronym / sponsor ID
- EMSIBD / Gastrolabor-IBD UKE
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Inflammatory bowel disease, Manometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 23 Jun 2015 (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.
Aims: Prospective evaluation of patients with a suspicion or diagnosis of Inflammatory bowel disease (IBD) to evaluate osophageal motility before and during therapy
Material and methods: The investigators prospectively perform manometry in patients with or with symptoms consistent with IBD. The investigators evaluate esophageal motility with high resolution manometry before, during and after IBD therapy. Clinical data are also collected to find possible correlations. The study do not modify the planned IBD therapy, but observe motility findings.
Detailed description
Oesophageal motility is measured with the high resolution manometry in order to detect pathologic peristaltic amplitude values among patient before and after therapy (mesalazine, steroids, biologicals) compared to the standard values detected among the normal population. Diagnosic intervention like oesophagoduodenoscopy, colonoscopy and stenosis ballon dilation are allowed as are part of the IBD therapy and follow up.
No other interventions are administered to participants during this study.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory bowel disease | Experimental | Device: ManometryPatients with Crohn's disease and ulcerative colitis undergoing manometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inflammatory bowel disease
- Suspicion of inflammatory bowel disease
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ManometryFlexible tube catheter pressure measurement of oesophageal contractions. Measurement without any sedation, transnasal | Device | Inflammatory bowel disease |
Primary outcome
Manometry finding (peristaltic amplitude values mmHG) compared to normal population findings
Time frame: 1 year
Correlation with gastrointestinal symptoms to manometry findings (peristaltic amplitude values)
Time frame: 1 year
1 secondary outcome
Manometry findings (peristaltic amplitude values, mmHG) during therapy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
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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.
Francesco Vitali, MD contact
Heinz Albrecht, MD study director
UK Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manometry in people with Inflammatory Bowel Disease, run by University Hospital Erlangen at 1 site in Germany.
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 2 inclusion and 1 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 30 Jun 2016. 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 Germany. 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 Francesco Vitali, MD (francesco.vitali@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manometry finding (peristaltic amplitude values mmHG) compared to normal population findings (time frame: 1 year). 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 30 Jun 2016.