Evaluating outcomes in eosinophilic gastrointestinal disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify the best measures for assessing the health of individuals with eosinophilic gastrointestinal disorders (EGIDs) such as eosinophilic esophagitis, gastritis, gastroenteritis, and colitis. Participants aged 3 years and older will undergo routine endoscopies and/or colonoscopies, during which biopsies will be collected for analysis. The study will compare tissue samples with clinical symptoms and utilize standard questionnaires to evaluate patient well-being over time. Participants will be followed longitudinally to track changes in their condition and quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males or females 3 years of age and older
* Mucosal eosinophilia:

EoE ≥ 15 eosinophils/HPF in the distal or proximal esophagus EoG ≥ 30 eosinophils/HPF in 5 HPF\'s in the body and/or antrum EoN ≥ 53 eosinophils/HPF in the duodenum and/or ≥ 56 eosinophils/HPF in the jejunum and/or ileum EoC ≥ 84 eosinophils/HPF from the transverse or descending colon and/or ≥ 32 eosinophils/HPF from the rectosigmoid colon or a biopsy from any colonic location with ≥ 100 eosinophils/HPF

\- Presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed.

Exclusion Criteria:

* History of intestinal surgery other than G tube placement
* Enrolled in a blinded investigational study at the time of the first study visit
* Have esophageal stricture (\<3mm)
* Have other identifiable causes for eosinophilia (except Inflammatory Bowel Disease): infections, Gastrointestinal (GI) cancer, other GI inflammatory disease (e.g., Ulcerative Colitis or Crohn\'s Disease)

Where it's running

• Mayo Clinic Hospital
  Phoenix, Arizona, United States Recruiting
• Arkansas Children's Research Institute
  Rogers, Arkansas, United States Recruiting
• Rady Children's Hospital
  San Diego, California, United States Recruiting
• University of Colorado Denver
  Aurora, Colorado, United States Recruiting
• Children's Hospital Colorado
  Denver, Colorado, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Marc E Rothenberg, MD, PhD — Cincinnati Children's Hospital Medical Center
• Study coordinator: Bliss Magella
• Email: bliss.magella@cchmc.org
• Phone: 513-636-7832

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry for Eosinophilic Gastrointestinal Disorders

  This study is collecting information from people with Eosinophilic Gastrointestinal Disorders to better understand their symptoms and improve treatments for them.

  Recruiting Ann & Robert H Lurie Children's Hospital of Chicago · Chicago, Illinois · NCT05199532

• Evaluating gastrointestinal eosinophilic disorders in children

  This study looks at how common eosinophilic gastrointestinal disorders are in children to help improve understanding and treatment of these conditions.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia · NCT05219903

• Upadacitinib for Eosinophilic Esophagitis in adults not responding to standard therapy

  This study tests whether upadacitinib, taken with topical corticosteroids, can reduce disease activity in adults with eosinophilic esophagitis who still have symptoms.

  Recruiting Phase 2 University of North Carolina, Chapel Hill · Chapel Hill, North Carolina and 1 other locations · NCT07588568

• A registry for adults with esophageal movement and reflux problems.

  This project will collect esophageal function tests (manometry, pH-impedance, FLIP) and clinical data from adults with reflux or swallowing symptoms to see if combining these results helps guide diagnosis and long-term care.

  Recruiting IRCCS San Raffaele · Milan, Lombardy · NCT07506746

• Dupilumab treatment for children with refractory eosinophilic gastrointestinal disorders

  We will try subcutaneous dupilumab injections in children with refractory EGIDs to see if symptoms, tissue eosinophils, and tolerability improve.

  Recruiting Children's Hospital of Fudan University · Shanghai · NCT07257835

• Using a mucosal impedance device to help diagnose chronic esophageal problems

  This test tries a mucosal impedance device during upper endoscopy to see if it helps diagnose people with chronic reflux (GERD) or eosinophilic esophagitis.

  Recruiting Medical College of Wisconsin · Milwaukee, Wisconsin · NCT07227506

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.