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

Primary Purpose

Inflammatory Bowel Disease

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Manometry

About this trial

This is an interventional screening trial for Inflammatory Bowel Disease focused on measuring Inflammatory bowel disease, Manometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inflammatory bowel disease
Suspicion of inflammatory bowel disease

Exclusion Criteria:

Pregnancy

Sites / Locations

University Hospital Erlangen NurembergRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inflammatory bowel disease

Arm Description

Patients with Crohn's disease and ulcerative colitis undergoing manometry

Outcomes

Primary Outcome Measures

Manometry finding (peristaltic amplitude values mmHG) compared to normal population findings

Correlation with gastrointestinal symptoms to manometry findings (peristaltic amplitude values)

Secondary Outcome Measures

Manometry findings (peristaltic amplitude values, mmHG) during therapy

Full Information

NCT ID

NCT02478944

First Posted

November 5, 2014

Last Updated

June 29, 2016

Sponsor

University Hospital Erlangen

1. Study Identification

Unique Protocol Identification Number

NCT02478944

Brief Title

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

Acronym

EMSIBD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Erlangen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Disease

Keywords

Inflammatory bowel disease, Manometry

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Inflammatory bowel disease

Arm Type

Experimental

Arm Description

Patients with Crohn's disease and ulcerative colitis undergoing manometry

Intervention Type

Device

Intervention Name(s)

Manometry

Intervention Description

Flexible tube catheter pressure measurement of oesophageal contractions. Measurement without any sedation, transnasal

Primary Outcome Measure Information:

Title

Manometry finding (peristaltic amplitude values mmHG) compared to normal population findings

Time Frame

1 year

Title

Correlation with gastrointestinal symptoms to manometry findings (peristaltic amplitude values)

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Manometry findings (peristaltic amplitude values, mmHG) during therapy

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inflammatory bowel disease Suspicion of inflammatory bowel disease Exclusion Criteria: Pregnancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francesco Vitali, MD

francesco.vitali@uk-erlangen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heinz Albrecht, MD

Organizational Affiliation

UK Erlangen

Official's Role

Study Director

Facility Information:

Facility Name

University Hospital Erlangen Nuremberg

City

Erlangen

State/Province

Bavaria

ZIP/Postal Code

91054

Country

Germany

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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