An observational study in Eosinophilic Gastrointestinal Disorders, Eosinophilic Esophagitis and Eosinophilic Gastritis or Gastroenteritis, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Recruiting at 1 site in Italy. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational
Eosinophilic gastrointestinal disorders (EGIDs) are a heterogeneous group of emerging chronic inflammatory diseases that may affect different gastrointestinal (GI) tracts. Based on the anatomical site involved, EGIDs are distinguished into eosinophilic esophagitis (EoE) and non-esophageal forms, which are subdivided into eosinophilic gastritis (EoG), gastroenteritis (EoGE), and colitis (EoC). EoE is considered the prototype of EGIDs. Since the first description of a case series of patients with EoE, fundamental scientific advances have been achieved, culminating in the redaction of international diagnostic and therapeutic guidelines. In contrast to EoE, non-esophageal forms of EGIDs are still a clinical enigma with evidence limited to a few retrospective studies. In the last decade, an increase in the prevalence of EGIDs has been observed in the pediatric age. Unfortunately, the epidemiology of EGIDs in Italy is still inconsistent and clear estimates are not available.
Firstly, this study will allow us to assess and clarify several clinical and epidemiological aspects of pediatric EGIDs, in particular:
This study has no ethical problems since EoE patients are treated according to international guidelines and those with non-esophageal EGIDs according to the latest scientific evidence.
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
This study's planned enrollment of 300 is above the median of 88 across 85 observational studies indexed under Eosinophilic Esophagitis.
Browse Eosinophilic Esophagitis studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.
Counted across the registry records on this site, refreshed daily.
EoE and EGIDs Definition: Based on current international guidelines, EoE diagnosis requires the presence of more than 15 eos/HPF in endoscopically obtained esophageal biopsies.5 In contrast, the diagnosis of non-esophageal EGIDs should meet the following criteria:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prevalence estimates
a) To estimate the EGIDs prevalence in patients with gastrointestinal symptoms undergoing upper and lower GI endoscopy, to verify whether the global increase of EGIDs also affects the Italian reality
Time frame: 5 years
Incidence estimates
b) If available the cumulative incidence (new EGIDs cases) may be derived, as a subgroup analysis of the primary endpoint
Time frame: 5 years
Prospective epidemiological estimates
a) To estimate the cumulative incidence of EGIDs (new diagnosis of EGIDs) over the study period.
Time frame: 5 years
Other epidemiological estimates
a) To compare the cumulative incidence of EGIDs observed in the prospective with the data from the retrospective study (if available) and those available in the literature, to verify the increase of EGIDs, previously observed in a few US observational studies;
Time frame: 5 years
Definition of clinical features and potential phenotypes
b) To describe the clinical characteristics of Italian patients with EGIDs (risk factors, sex, age, comorbidities, response to therapy, natural history), to identify potential phenotypes;
Time frame: 5 years
Improvement of diagnostic and therapeutic management
c) To define shared diagnostic-therapeutic management and verify the adherence of enrolled centers to the international EoE guidelines.
Time frame: 5 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Fondazione IRCCS Policlinico San Matteo di Pavia →