Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry.

NCT ID: NCT02331849

Last Updated: 2015-01-06

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Brief Summary

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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.

Detailed Description

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After identification of eosinophilic inflammation of the esophagus -\> differentiation between GERD and eosinophilic esophagitis (via pH/MII-measurements or PPI-trial) -\> High-resolution manometry (HRM) for evaluation of esophageal motility in patients with eosinophilic esophagitis (exclusion of GERD-patients)-\> initiation of budesonide-therapy -\> after eight weeks of therapy reevaluation of esophageal motility by HRM

Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Eosinophilic esophagitis

Patients with eosinophilic esophagitis after exclusion of GERD

Group Type OTHER

High resolution manometry (HRM)

Intervention Type DEVICE

High resolution manometry of the esophagus

Interventions

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High resolution manometry (HRM)

High resolution manometry of the esophagus

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

• patients with eosinophilic inflammation of the esophagus

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Monther Bajbouj

PD Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon Nennstiel, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar, II. Med. Klinik

Christoph Schlag, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar, II. Med. Klinik

Monther Bajbouj, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar, II. Med. Klinik

Locations

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Klinikum rechts der Isar, II. Medizinische Klinik

München, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Simon Nennstiel

Role: CONTACT

+49 89 4140 5055

Christoph Schlag

Role: CONTACT

+49 89 4140 5055

Facility Contacts

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Simon Nennstiel

Role: primary

+40 89 4140 5055

References

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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.

Reference Type DERIVED
PMID: 30614939 (View on PubMed)

Other Identifiers

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HIMEOS-2013

Identifier Type: -

Identifier Source: org_study_id

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