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

NCT ID: NCT02478944

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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

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Inflammatory Bowel Disease

Keywords

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Inflammatory bowel disease Manometry

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Inflammatory bowel disease

Patients with Crohn's disease and ulcerative colitis undergoing manometry

Group Type EXPERIMENTAL

Manometry

Intervention Type DEVICE

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

Interventions

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Manometry

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Inflammatory bowel disease
* Suspicion of inflammatory bowel disease

Exclusion Criteria

* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Erlangen

OTHER

Sponsor Role lead

Responsible Party

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Francesco Vitali

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heinz Albrecht, MD

Role: STUDY_DIRECTOR

UK Erlangen

Locations

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University Hospital Erlangen Nuremberg

Erlangen, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Francesco Vitali, MD

Role: CONTACT

Email: [email protected]

Other Identifiers

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Gastrolabor-IBD UKE

Identifier Type: -

Identifier Source: org_study_id