Esophageal Motility Disease Screening in Patient With Suspicion or Diagnosis of IBD

Inflammatory Bowel Disease Clinical Trial

— EMSIBD  

Official title:

Esophageal Motility Disease Screening in Patient With Suspicion or Diagnosis of IBD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02478944
• Other study ID #: Gastrolabor-IBD UKE
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2014
• Last updated: June 29, 2016
• Start date: October 2014
• Est. completion date: January 2017

Study information

• Verified date: June 2016
• Source: University Hospital Erlangen
• Contact: Francesco Vitali, MD
• Email: francesco.vitali[@]uk-erlangen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inflammatory bowel disease

• Suspicion of inflammatory bowel disease

Exclusion Criteria:

• Pregnancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Device:
• Manometry
Flexible tube catheter pressure measurement of oesophageal contractions. Measurement without any sedation, transnasal

Locations

Country	Name	City	State
Germany	University Hospital Erlangen Nuremberg	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Erlangen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manometry finding (peristaltic amplitude values mmHG) compared to normal population findings		1 year	No
Primary	Correlation with gastrointestinal symptoms to manometry findings (peristaltic amplitude values)		1 year	No
Secondary	Manometry findings (peristaltic amplitude values, mmHG) during therapy		1 year	No