Primary objective: To investigate the effects of fully inhibiting type 2 inflammation on esophageal mucosal barrier function and inflammation in adult EoE patients. Secondary objective: To evaluate the effect of type 2 inflammation and the IL4 /…
ID
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Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the effects of fully inhibiting type 2 inflammation on
esophageal mucosal barrier function and inflammation in adult EoE patients.
Secondary outcome
To evaluate the effect of type 2 inflammation and the IL4 / IL13 pathway in
particular on food-induced immune responses in esophageal biopsy specimens
exposed to different food allergens ex vivo.
Background summary
Eosinophilic esophagitis (EoE) is an allergic inflammation of the esophagus. If
not treated properly, inflammation and narrowing of the esophagus can occur.
This can eventually lead to food impaction.
Food allergens play an important role in the pathogenesis of EoE, as
demonstrated by endoscopic and clinical resolution of EoE once the causative
food is removed from the diet and exacerbation when the same food is
reintroduced Similarly, amino acid-based elemental diets are effective in both
adults and children with EoE. However, the exact mechanism by which food
allergens can initiate inflammation in EoE is still unknown, as there are
limited data on the early local esophageal immune response after challenge with
a specific food trigger.
Previous research has shown that this can be treated with antacids (PPI) and
corticosteroids. This reduces the permeability of the esophagus (which is
increased in EoE), but not to the level of healthy individuals. Most likely
this is due to a mild underlying allergic inflammation that persists under
treatment with the above agents. The idea is that dupilumab inhibits this type
II inflammation, which will further reduce the permeability.
In addition, the effect of food allergens on esophageal biopsies from both EoE
patients and healthy patients will be examined. This will then be compared to
the biopsies taken after the use of dupilumab.
Study objective
Primary objective:
To investigate the effects of fully inhibiting type 2 inflammation on
esophageal mucosal barrier function and inflammation in adult EoE patients.
Secondary objective:
To evaluate the effect of type 2 inflammation and the IL4 / IL13 pathway in
particular on food-induced immune responses in esophageal biopsy specimens
exposed to different food allergens ex vivo.
Study design
Prospective observation study clarifying pathophysiology of EoE, in which the
effects of the type 2 inflammatory pathway are studied in patients that in
regular patient care receive a treatment that completely inhibits this pathway.
Esophageal permeability and inflammation in EoE patients will be compared with
measurements in 10 non-EoE controls and with the EoE patients themselves during
IL4/IL13 blockade.
Furthermore, we would like to take biopsies in another 20 EoE subjects with
active disease for our further ex vivo experiments in which response of the
esophageal tissue with food allergens is studied.
Intervention
A resistance measurement is done and 16 additional biopsies are taken during
the stomach examination (gastroscopy). The gastroscopy would anyway already a
potential, potential of patient participates in the study. In addition, blood
will be earned and the patient is asked to fill out a questionnaire.
Study burden and risks
None
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
EoE patient group with dupilumab
• Previous diagnosis of active EoE confirmed by histopathology e.g. presence of
>15 eosinophilic granulocytes per hpf in mid or proximal oesophageal biopsies
• Scheduled to start with dupilumab as regular care
• 18 to 75 years of age
• Written informed consent must be obtained and documented
EoE patient group with active EoE
• Previous diagnosis of active EoE confirmed by histopathology e.g. presence of
>15 eosinophilic granulocytes per hpf in mid or proximal esophageal biopsies
• Scheduled for an upper endoscopy
• 18 to 75 years of age
• Written informed consent must be obtained and documented
Non-EoE control group
• Scheduled for a upper endoscopy for other, non-EoE related, symptoms
• 18 to 75 years of age
• Written informed consent must be obtained and documented
Exclusion criteria
EoE patient group
• Use of oral or systemic antihistaminics, oral cromoglicates, systemic
corticoster-oids, leukotriene inhibitors, or monoclonal antibodies, in the
month preceding the study
• Proven gastroesophageal reflux disease or other cause for esophageal
eosinophil-ia
• History of peptic ulcer disease
• History of Barrett*s esophagus
• History of GI cancer
• ASA class III, IV or V
Non-EoE control group
• Symptoms suggestive of esophageal disease
• Personal history of atopic, skin or systemic diseases
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 | NL87737.018.24 |