CClinicalTrials.gg
Status unknownNCT02478944EMSIBDUpdated Jun 30, 2016

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

An interventional study of Manometry in Inflammatory Bowel Disease, sponsored by University Hospital Erlangen. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-30.

Sponsored by University Hospital Erlangen · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Inflammatory Bowel Disease

Keywords

  • Inflammatory bowel disease
  • Manometry
03

In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 552 interventional studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

University Hospital Erlangen is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Inflammatory bowel disease
  • Suspicion of inflammatory bowel disease

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Inflammatory bowel disease

    Patients with Crohn's disease and ulcerative colitis undergoing manometry

    Device: Manometry

Interventions

  • DeviceManometry

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

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

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

    Time frame: 1 year

Secondary outcomes

  1. Manometry findings (peristaltic amplitude values, mmHG) during therapy

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • University Hospital Erlangen Nuremberg
    Erlangen, Bavaria 91054, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02478944
Lead sponsor
University Hospital Erlangen
Responsible party
Francesco Vitali (MD, University Hospital Erlangen) — Principal investigator
First posted
Jun 23, 2015
Start date
Oct 2014
Primary completion
Dec 2016 (estimated)
Completion
Jan 2017 (estimated)
Last update
Jun 30, 2016

Study contacts

Francesco Vitali, MD
Contact
francesco.vitali@uk-erlangen.de
Heinz Albrecht, MD
study director · UK Erlangen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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