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

Not Applicable

• Conditions: Inflammatory Bowel Disease
• Interventions: Device: Manometry

• Registration Number: NCT02478944
• Lead Sponsor: University Hospital Erlangen

Brief 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.

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-23
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-06-30
• Primary Completion: 2016-12
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Inflammatory bowel disease
• Suspicion of inflammatory bowel disease

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inflammatory bowel disease	Manometry	Patients with Crohn's disease and ulcerative colitis undergoing manometry

Primary Outcome Measures

Name	Time	Method
Manometry finding (peristaltic amplitude values mmHG) compared to normal population findings	1 year
Correlation with gastrointestinal symptoms to manometry findings (peristaltic amplitude values)	1 year

Secondary Outcome Measures

Name	Time	Method
Manometry findings (peristaltic amplitude values, mmHG) during therapy	1 year

Trial Locations

Locations (1)

University Hospital Erlangen Nuremberg; 🇩🇪 Erlangen, Bavaria, Germany