Amsterdam UMC
Amsterdam, North Holland, 1081HV, Netherlands
Location status: Recruiting
Location contact
Albert J. Bredenoord
CONTACT
Arjan Bredenoord
PRINCIPAL_INVESTIGATOR
Mandy Fijnenberg
CONTACT
Mandy Fijnenberg
SUB_INVESTIGATOR
NCT Number: NCT07012928
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Amsterdam, North Holland, 1081HV, Netherlands
Location status: Recruiting
Albert J. Bredenoord
CONTACT
Arjan Bredenoord
PRINCIPAL_INVESTIGATOR
Mandy Fijnenberg
CONTACT
Mandy Fijnenberg
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
EoE patient group with dupilumab or topical budesonide Previous diagnosis of active EoE confirmed by histopathology e.g. presence of 15 or more eosinophilic granulocytes per hpf in mid or proximal esophageal biopsies Scheduled to start with dupilumab or topical budesonide 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 or more 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-esophageal related, symptoms 18 to 75 years of age Written informed consent must be obtained and documented
Exclusion criteria
EoE patient group with dupilumab, topical budesonide and with active EoE Use of oral or systemic antihistaminics, oral cromoglicates, systemic corticosteroids, leukotriene inhibitors or monoclonal antibodies, in the month preceding the study Proven gastroesophageal reflux disease or other cause for esophageal eosinophilia, History of peptic ulcer disease, History of Barrett's esophagus, History of gastro intestinal cancer or ASA class III, IV or V
Non-EoE control group Symptoms suggestive of esophageal disease or other disease that may infolve the esophagus Personal history of atopic, skin or systemic diseases
Time frame: 26 weeks after dupilumab
Esophagael barrier function improvement after 26 week of dupilumab treatment in EoE patients, assessed by the change in transepithelial electrical resistance (TEER).
Time frame: 26 weeks after dupilumab
food-induced immune responses in esophageal biopsy specimens exposed to different food allergens ex vivo after dupilumab.
Contact information is provided by the study sponsor or research team.
Albert J. Bredenoord, gastroenterologist
CONTACT
Mandy Fijnenberg, WO medicine
CONTACT
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
Acronym: SINFONIA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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