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Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 1 Month - 18 Years
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03858426
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, , 28222

Site Contact

Carolina Gutierrez Junquera, PhD

carolina.gutijun@salud.madrid.org

911916437

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