Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry.
HIMEOS
1 other identifier
interventional
20
1 country
1
Brief Summary
Esophageal Motility in eosinophilic esophagitis will be evaluated by High Resolution Manometry before and after medical treatment - motility is suspected to change/improve after therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 2, 2013
CompletedFirst Posted
Study publicly available on registry
January 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedJanuary 6, 2015
January 1, 2015
1.3 years
December 2, 2013
January 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement of esophageal motility (IBP) measureable in high resolution manometry (HRM)
Average maximum intra-bolus-pressure (IBP) \[mmHg\] before and after therapy
Two months
Secondary Outcomes (3)
Improvement of esophageal motility (e.g. specified in the chicago classification) represented in high resolution manometry (HRM)
Two months
Endoscopic evaluation of inflammation before/after therapy
Two months
Symptoms before/after therapy
Two months
Study Arms (1)
Eosinophilic esophagitis
OTHERPatients with eosinophilic esophagitis after exclusion of GERD
Interventions
High resolution manometry of the esophagus
Eligibility Criteria
You may qualify if:
- patients with eosinophilic inflammation of the esophagus
You may not qualify if:
- refusal to participate in study
- pregnancy
- eosinophilic gastroenteritis
- Achalasia
- contraindication for gastroscopy / HRM / 24-h-pH/Impedance-monitoring
- contraindication for therapy with budesonide
- eosinophilic inflammation due to GERD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum rechts der Isar, II. Medizinische Klinik
München, 81675, Germany
Related Publications (1)
Weidlich S, Nennstiel S, Jesinghaus M, Brockow K, Slotta-Huspenina J, Bajbouj M, Schmid RM, Schlag C. IgG4 is Elevated in Eosinophilic Esophagitis but Not in Gastroesophageal Reflux Disease Patients. J Clin Gastroenterol. 2020 Jan;54(1):43-49. doi: 10.1097/MCG.0000000000001154.
PMID: 30614939DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Nennstiel, Dr. med.
Klinikum rechts der Isar, II. Med. Klinik
- PRINCIPAL INVESTIGATOR
Christoph Schlag, Dr. med.
Klinikum rechts der Isar, II. Med. Klinik
- PRINCIPAL INVESTIGATOR
Monther Bajbouj, PD Dr. med.
Klinikum rechts der Isar, II. Med. Klinik
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. med.
Study Record Dates
First Submitted
December 2, 2013
First Posted
January 6, 2015
Study Start
October 1, 2013
Primary Completion
February 1, 2015
Last Updated
January 6, 2015
Record last verified: 2015-01