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Eosinophilic Esophagitis (EoE) Intervention Trial-Randomized 1 Food Elimination vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Collaborator:
Collaborator: Patient Centered Outcome Research Institute (PCORI)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT02610816
First received: October 12, 2015
Last updated: June 6, 2016
Last verified: June 2016
  Purpose
The purpose of this interventional study is to test and compare the effectiveness of two elimination diets—the 1-food elimination diet (1FED, milk only) and the 4-food elimination diet (4FED, milk, egg, wheat, and soy). The study will also test the effectiveness of swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was not effective.

Condition Intervention Phase
Eosinophilic Esophagitis
Eosinophilic Gastrointestinal Disorders (EGIDs),
Other: elimination diet therapy
Drug: Flovent (fluticasone propionate)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Eosinophilic Esophagitis (EoE) Intervention Trial-Randomized 1 Food Elimination vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Change in Pediatric EoE Symptom Score (PEESS, version 2) from pre-treatment to post-treatment. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Rate of histologic remission following 1FED or 4FED therapy (Phase 1). [ Time Frame: 12 weeks ]
  • Rate of remission following swallowed glucocorticoid therapy in the 4FED diet non-responders (Phase 2). [ Time Frame: 12 weeks ]

Estimated Enrollment: 292
Study Start Date: January 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phase 1
Phase 1 will evaluate the effectiveness of the 1FED and the 4FED.
Other: elimination diet therapy

1FED: milk elimination 4FED: milk, egg, wheat, and soy elimination

Other Names:

  • 1FED
  • 4FED
Active Comparator: Phase 2
Phase 2 will evaluate the effectiveness of the 4FED in 1FED non-responders and the effectiveness of swallowed glucocorticoids (Flovent, fluticasone propionate) in the 4FED non-responders.
Other: elimination diet therapy

1FED: milk elimination 4FED: milk, egg, wheat, and soy elimination

Other Names:

  • 1FED
  • 4FED
Drug: Flovent (fluticasone propionate)

Drug: Flovent

Flovent (fluticasone propionate): swallowed glucocorticoid

Other Names:

•fluticasone propionate


Detailed Description:

This study will consist of two phases, plus a screening period. During the screening period, subject eligibility for the study will be determined. During Phase 1, qualified participants will be randomly assigned to one of two elimination diet therapies--the 1FED or the 4FED. Participants will remain on the assigned dietary therapy for 12 weeks. At the end of 12 weeks of therapy, esophageal biopsies from participant's standard of care (i.e. normal, routine care) endoscopy will be evaluated to determine disease status. Participants whose EoE is in remission (i.e. <15 eos/hpf) will be done with the study.

Participants whose EoE is still active (i.e. ≥15 eos/hpf) will continue into Phase 2 of the study. During Phase 2, participants who were on 1FED in Phase 1 will receive 4FED therapy for 12 weeks, and participants who were on 4FED during Phase 1 will receive swallowed glucocorticoid therapy for 12 weeks. At the end of 12 weeks of therapy, esophageal biopsies from participant's standard of care (i.e. normal, routine care) endoscopy will be evaluated to determine disease status.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have diagnosis of EoE (based on consensus criteria)
  • Are aged 6 to 17 years
  • Have histologically confirmed active disease >15 eosinophils/hpf in either distal or proximal esophagus within 4 weeks of screening visit
  • PPI confirmation
  • Symptomatic (have experienced symptoms within the last month prior to enrollment)
  • Has a negative urine pregnancy test at screening if of childbearing potential. Females of childbearing potential must have a negative urine pregnancy test (β-hCG) prior to enrollment into the study (i.e., at screening). Subsequently, these participants must agree to use adequate birth control measures (e.g., condom, oral/injectable/subcutaneous contraceptives, intrauterine device, or sexual abstinence) during the study and for at least one month after the last dose of study drug which will be documented in the source documents.

Exclusion Criteria:

  • Have been treated with topical swallowed steroids within the last 2 months or systemic steroids within the past 3 months
  • Have eosinophilia in segments of the GI tract other than the esophagus
  • Have been diagnosed with a GI malabsorption disorder (i.e., Inflammatory bowel disease, Crohn's disease) or Celiac disease
  • Are currently on dietary therapy avoiding milk
  • Have concurrent H pylori gastritis or parasitic infection
  • Are unable to obtain EGD with esophageal biopsies at CCHMC or other participating institution within 4 weeks of study completion
  • Have previously failed (in a clinical trial setting) dietary therapy with one of these regimens or topical steroid treatment with fluticasone at a total dose of 1760 mcg per day.
  • Have definitely responded (in a clinical trial setting) to either dietary therapy avoiding these antigens or to swallowed fluticasone at a total dose of 1760 mcg per day
  • Are concurrently receiving any of the prohibited medications listed in Table 2
  • On immunotherapy for pollen (if not on maintenance therapy) or IgE-mediated food allergy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02610816

Contacts
Contact: Kara Kliewer, PhD, RD 513-636-4821 kara.kliewer@cchmc.org
Contact: Jonathan Kuhl, BS 513-803-3078 jonathan.kuhl@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Marc Rothenberg, MD         
Contact: Melody Hess    513-636-5540    melody.hess@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Collaborator: Patient Centered Outcome Research Institute (PCORI)
Investigators
Principal Investigator: Marc E Rothenberg, MD, PhD Children's Hospital Medical Center, Cincinnati
  More Information

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02610816     History of Changes
Other Study ID Numbers: 2015-2187
Study First Received: October 12, 2015
Last Updated: June 6, 2016

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Digestive System Diseases
Gastrointestinal Diseases
Esophageal Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Glucocorticoids
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on March 27, 2017