NCT02478944

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

November 5, 2014

Last Update Submit

June 29, 2016

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory bowel diseaseManometry

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Manometry findings (peristaltic amplitude values, mmHG) during therapy

    1 year

Study Arms (1)

Inflammatory bowel disease

EXPERIMENTAL

Patients with Crohn's disease and ulcerative colitis undergoing manometry

Device: Manometry

Interventions

ManometryDEVICE

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

Inflammatory bowel disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inflammatory bowel disease
  • Suspicion of inflammatory bowel disease

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Erlangen Nuremberg

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Manometry

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Heinz Albrecht, MD

    UK Erlangen

    STUDY DIRECTOR

Central Study Contacts

Francesco Vitali, MD

CONTACT

francesco.vitali@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 5, 2014

First Posted

June 23, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

June 30, 2016

Record last verified: 2016-06

Locations

DE(1)