Natural History of Eosinophilic Esophagitis in Adult and Pediatric Population
Natural History of Eosinophilic Esophagitis in Adult and Pediatric Population: a Multicentric Prospective Study in Italy
Eosinophilic esophagitis (EoE) is a Th2-mediated disease induced by ingestion of ambiental and alimentary allergens. Incidence of EoE is increasing in recent years. Young male subjects are more often affected by EoE. Esophageal eosinophilic infiltrate causes different symptoms of esophageal dysfunction (i.e. dysphagia, food impaction, chest pain, heartburn). In pediatric population symptoms are nonspecific (failure to thrive, vomiting) and more common to be misdiagnosed.
Symptoms are commonly sporadic and underestimated by the patients. Therefore, specialistic evaluations are often delayed during the following months and years. Moreover, esophageal symptoms are often not investigated or associated with other diseases especially in pediatric population (i.e. gastroesophageal reflux disease). For this reason, diagnosis of EoE is often delayed. It is known from literature that diagnostic delay in EoE causes prolonged inflammation of the esophagus that may lead to esophageal fibrosis and stenosis with worsening of symptoms. Proton pump inhibitors (PPIs) and topical steroids are the first line medicines to induce EoE remission. Prolonged clinical remission is described in 60% of adult patients with PPIs. Recently orodispersible budesonide showed clinical remission after 1 year nearby in 90% of adult patients. Orodispersible budesonide is effective also in chidren with an efficacy in maintaining remission at lowest effective dosage after 60 weeks in around 78% of patients. Dysphagia Symptom Questionnaire (DSQ) is a validated tool used in order to measure clinical activity (dysphagia) in adult and pediatric patients with EoE. Italian version of the DSQ is not available in literature. Little is known in literature about the natural history of EoE patients, in particular about sustained clinical remission and appearance of complications (i.e. food impaction) during a prolonged follow-up period. Aim of our two-phase prospective study is to evaluate the clinical and endoscopic response at the current available therapies and the appearance of complications during a prolonged follow-up period in a cohort of adult and pediatric population.
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Pavia
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Pavia, Pavia, 이탈리아, 27100
- 모병
- Fondazione IRCCS Policlinico San Matteo di Pavia
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연락하다:
- Antonio Di Sabatino, Medicine
- 전화번호: 0382 502973
- 이메일: a.disabatino@smatteo.pv.it
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연락하다:
- Carlo Rossi, Medicine
- 전화번호: 00390382502842
- 이메일: ca.rossi@smatteo.pv.it
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Pavia, Pavia, 이탈리아, 27100
- 모병
- S. C. General Medicine I, Fondazione IRCCS Policlinico San MAtteo
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연락하다:
- Carlo Rossi, Medicine
- 전화번호: 00390382502842
- 이메일: ca.rossi@smatteo.pv.it
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연락하다:
- Antonio Di Sabatino, Medicine
- 전화번호: 00390382502973
- 이메일: a.disabatino@smatteo.pv.it
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- patients with an established diagnosis of Eosinophilic esophagitis;
- aged ≥5 years;
- who gave written informed consent.
Exclusion Criteria:
- under 5 years old;
- Patients who are illiterate;
- Patients who are unwilling to participate
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Adult cohort
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Paediatric cohort
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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To evaluate the repeatability (test-retest reliability) of the Italian version of DSQ questionnaire at enrollment and at 1 months afterwards.
기간: 1 months afterwards the enrollment
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The Intraclass correlation coefficient (ICC) will be calculated to evaluate the test-retest reliability of the Italian version of DSQ questionnaire.
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1 months afterwards the enrollment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Maintenance of remission in the follow-up period in both in EoE adult and paediatric patients.
기간: every year for 5 years total
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To calculate the cumulative proportion of maintenance of remission in the follow-up period will be estimated using Kaplan-Meier failure estimator both in EoE adult and paediatric patients.
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every year for 5 years total
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .