Eosinophilic EsophagitisHIMEOSNCT02331849
Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry.
A study testing High resolution manometry (HRM) in people with Eosinophilic Esophagitis, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- High resolution manometry (HRM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with eosinophilic inflammation of the esophagus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum rechts der Isar, II. Medizinische Klinik
München, 81675
Simon Nennstiel, +40 89 4140 5055, simon.nennstiel@lrz.tum.de
About this study
Official title: Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry - Effect on Esophageal Motility of Standard Therapy.
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.
Read the detailed description
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
- Eosinophilic Esophagitis
- Being tested
- High resolution manometry (HRM)
- Keywords
- Eosinophilic esophagitis (EoE), GERD, esophageal motility
- Medical subject headings
- Eosinophilic Esophagitis, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution manometry (HRM)Device
High resolution manometry of the esophagus
| Study group | Role | What they receive |
|---|---|---|
| Eosinophilic esophagitis | Other | Patients with eosinophilic esophagitis after exclusion of GERD Receives: Device: High resolution manometry (HRM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of esophageal motility (IBP) measureable in high resolution manometry (HRM)
Average maximum intra-bolus-pressure (IBP) [mmHg] before and after therapy
Measured: Two months
Secondary outcomes (3)
Improvement of esophageal motility (e.g. specified in the chicago classification) represented in high resolution manometry (HRM)
weak peristalsis with small/large breaks, frequently failes peristalsis, absent peristalsis, hypertensive peristalsis, rapid contractions with normal latency, functional EGJ-obstruction, panesophageal pressurizations, compartimentalized pressurizations;
Measured: Two months
Endoscopic evaluation of inflammation before/after therapy
Endoscopic assessment of esophageal signs of eosinophilic esophagitis (white exsudates, furrows, edema, rings, crepe paper, stricture
Measured: Two months
Symptoms before/after therapy
Evaluation of symptoms via questionnaire before/after therapy
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startOct 2013
- Primary completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monther Bajbouj, Technical University of Munich
- Investigators
- Simon Nennstiel, Dr. med., Principal investigator, Klinikum rechts der Isar, II. Med. KlinikChristoph Schlag, Dr. med., Principal investigator, Klinikum rechts der Isar, II. Med. KlinikMonther Bajbouj, PD Dr. med., Principal investigator, Klinikum rechts der Isar, II. Med. Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331849
- Sponsor's protocol ID
- HIMEOS-2013
- Acronym
- HIMEOS
- Status last verified
- Jan 2015
- First submitted
- 2 Dec 2013
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30614939
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry - Effect on Esophageal Motility of Standard Therapy.
- ClinicalTrials.gov ID
- NCT02331849
- Acronym / sponsor ID
- HIMEOS / HIMEOS-2013
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic esophagitis (EoE), GERD, esophageal motility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eosinophilic esophagitis | Other | Device: High resolution manometry (HRM)Patients with eosinophilic esophagitis after exclusion of GERD |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with eosinophilic inflammation of the esophagus
Key exclusion criteria (7 listed)
- refusal to participate in study
- pregnancy
- eosinophilic gastroenteritis
- Achalasia
- contraindication for gastroscopy / HRM / 24-h-pH/Impedance-monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High resolution manometry (HRM)High resolution manometry of the esophagus | Device | Eosinophilic esophagitis |
Primary outcome
Improvement of esophageal motility (IBP) measureable in high resolution manometry (HRM)
Time frame: Two months
Average maximum intra-bolus-pressure (IBP) [mmHg] before and after therapy
3 secondary outcomes
Improvement of esophageal motility (e.g. specified in the chicago classification) represented in high resolution manometry (HRM)
Time frame: Two months
Endoscopic evaluation of inflammation before/after therapy
Time frame: Two months
Symptoms before/after therapy
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Derived from this study: PubMed 30614939Weidlich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Nennstiel, Dr. med. principal investigator
Klinikum rechts der Isar, II. Med. Klinik
Christoph Schlag, Dr. med. principal investigator
Klinikum rechts der Isar, II. Med. Klinik
Monther Bajbouj, PD Dr. med. principal investigator
Klinikum rechts der Isar, II. Med. Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High resolution manometry (HRM) in people with Eosinophilic Esophagitis, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Nennstiel (+49 89 4140 5055, simon.nennstiel@lrz.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of esophageal motility (IBP) measureable in high resolution manometry (HRM) (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02331849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.