1. To investigate esophageal sensitivity to acid infusion and balloon distension in eosinophilic esophagitis patients with histological active disease and disease in remission, as compared to healthy controls 2. To investigate the difference in…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measures of sensitivity of the esophagus:
1. Perfusion sensitivity scores in histological active disease, disease in
remission and healthy controls, calculated via [(total perfusion time * lag
time to perception) x maximum VAS]
2. Balloon pressure that induced a sensation of discomfort in histological
active disease, disease in remission and healthy controls
Secondary outcome
1. Esophageal barrier function in histological active disease and disease in
remission, defined as electrical tissue impedance measured with ETIS and
transepithelial electrical resistance and fluorescein flux measured in Ussing
chamber
2. The degree of reflux in the EoE patients, as measured with 24-hours pH-
impedance measurement
Background summary
Eosinophilic esophagitis (EoE) is chronic inflammatory condition of the
esophagus, characterized by symptoms of esophageal dysfunction, such as
dysphagia and food impactions. Different treatment options are available for
EoE patients, such as acid suppressive medication, dietary treatment and
topical steroids. One study suggests that EoE patients with active disease are
more sensitive to physiological quantities of acid. We would like to
investigate if the observed hypersensitivity also exists in patients with
histological disease in remission. One of the problems of treating EoE patients
is that in some patients symptoms persists after histological remission has
been achieved. We wonder if persistent hypersensitivity explains why some
patients with histological disease in remission remain symptomatic. In the
present study we would further elucidate presence of hypersensitivity in EoE
and its relation to the esophageal mucosal integrity.
Study objective
1. To investigate esophageal sensitivity to acid infusion and balloon
distension in eosinophilic esophagitis patients with histological active
disease and disease in remission, as compared to healthy controls
2. To investigate the difference in esophageal sensitivity to acid infusion and
balloon distension between eosinophilic esophagitis patients with histological
disease in remission who remain symptomatic and patients that are histological
and clinical in remission
3. To investigate the relationship between esophageal sensitivity and mucosal
integrity
4. To investigate the presence of GERD and its influence on the sensitivity to
acid perfusion and on mucosal integrity
Study design
Prospective, single centre study
Intervention
An acid perfusion test and barostat balloon distention test will be performed
in EoE patients at baseline. This will be repeated in the EoE patients after
6-8 weeks of topical budesonide standard treatment. To investigate the
relationship between the esophageal sensitivity and the mucosal integrity in
EoE patients a gastroscopy will be conducted, in which ETIS is performed and
biopsies are taken for the Ussing chambers. In order to investigate the
potential influence of concurrent GERD, EoE patients undergo a 24-Ph impedance
measurement.
Study burden and risks
The burden of participation in this study is a total of 4 visits for EoE
patients. Gastroscopy with biopsies is a routinely performed, safe
investigation to evaluate disease activity in EoE patients. Patients are not
exposed to additional risks, however, the duration of the procedure is slightly
extended due to the ETIS and additional biopsies taken. Balloon distention test
and acid perfusion test are commonly used for assessing esophageal sensitivity,
no complication have been described. Participants will be compensated
financially for participation in the study and the findings could help us
better understand symptom perception in eosinophilic esophagitis patients.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Previous diagnosis of active EoE confirmed by histopathology e.g. presence of
>15 eosinophilic granulocytes per high power field (hpf) in esophageal biopsies
- Written informed consent
- Age 18-75 years
Exclusion criteria
- Any form of treatment for EoE (topical corticosteroids, PPI or dietary
treatment) in the month preceding the study
- ASA class III, IV or V
- The need for pain medication 24 hours before the visit
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72089.018.19 |