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Trial record 6 of 141 for:    "eosinophilic esophagitis"

Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis (RENESE)

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ClinicalTrials.gov Identifier: NCT03858426
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Carolina Gutierrez Junquera, Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica

Brief Summary:
  1. Registry of demographic, clinical, endoscopic and histological data at baseline.
  2. Registry of patients treated with PPI:

    • Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
    • Clinical, endoscopic and histological response at 6 and 12 months weeks of maintenance treatment
  3. Registry of patients treated with two foods elimination diet:

    • Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
    • Identification of food trigger: milk, gluten or milk and gluten
    • Clinical, endoscopic and histological response at one year elimination of food trigger
    • Registry of adverse events
  4. Registry of patients treated with swallowed steroids (budesonide or fluticasone):

    • Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
    • Clinical, endoscopic and histological response at 6 months of maintenance steroid treatment
    • Registry of adverse events

Condition or disease Intervention/treatment
Eosinophilic Esophagitis Other: no intervention

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : July 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Children with eosinophilic esophagitis

Inclusion criteria:

  • Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis according to recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus > 15 eos / CGA)
  • And they need to start treatment with one of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids

Exclusion criteria:

  • Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis)
  • Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).
Other: no intervention
no intervention




Primary Outcome Measures :
  1. Complete histological remission [ Time Frame: 12 weeks ]
    Complete histological remission response defined as ≤5 eosinophils/hpf in all biopsies performed


Secondary Outcome Measures :
  1. Partial histological remission [ Time Frame: 12 weeks ]
    Partial histological remission response defined as 5-15 eosinophils /hpf in all biopsies

  2. Clinical remission [ Time Frame: 12 weeks ]
    Clinical remission (specific questionnaire)



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis according to the recent European guidelines
Criteria

Inclusion Criteria:

  • Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis (EoE) according to the recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus > 15 eos / CGA)
  • And that they need to start treatment with any of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids .

Exclusion Criteria:

  • Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis)
  • Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858426


Contacts
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Contact: Carolina Gutierrez-Junquera, MD, PHD +34911916437 carolina.gutijun@salud.madrid.org
Contact: Belén Ruiz-Antorán, MD, PHD +34911917479 mariabelen.ruiz@salud.madrid.org

Locations
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Spain
Hospital Universitario Puerta de Hierro Majadahonda Recruiting
Madrid, Spain, 28222
Contact: Carolina Gutierrez Junquera, PhD    911916437    carolina.gutijun@salud.madrid.org   
Sponsors and Collaborators
Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica

Additional Information:

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Responsible Party: Carolina Gutierrez Junquera, Principal Investigator, Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
ClinicalTrials.gov Identifier: NCT03858426     History of Changes
Other Study ID Numbers: RENESE
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carolina Gutierrez Junquera, Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica:
Eosinophilic Esophagitis; PPIs, children, elimination diet, topical steroids

Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases