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A Food Additive Removal Diet for Pediatric Eosinophilic Esophagitis (FREE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03657771
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
James Franciosi, Nemours Children's Clinic

Brief Summary:
Prospective, pragmatic standard of care clinical trial comparing dietary therapies of standard dairy elimination diet alone (DED) to dairy elimination plus food additive elimination (FREE)

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Other: DED Other: FREE Not Applicable

Detailed Description:

Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder of the esophagus. Primary symptoms manifest while eating and include dysphagia, chest pain, and food impaction. EoE was first described in the 1990s, but is increasingly recognized worldwide. It affects both adults and children.

Given that EoE is thought to be an allergen driven disease, elimination diets are considered logical and safe first-line treatment options. Elimination diets focus on the removal of the food groups most likely to evoke the inflammatory response (e.g. dairy, wheat, soy, egg, etc.). This is the first study to examine the effects of an additive free diet on eosinophilic esophagitis.

Primary Objective: To compare histologic outcomes (eosinophils per high power field: eos/hpf) of DED and FREE in children with eosinophilic esophagitis.

Secondary Objective: To compare endoscopic outcomes (Eosinophilic Esophagitis Endoscopic Reference scores: EREFs) of DED and FREE in children with eosinophilic esophagitis

Tertiary Objectives: To compare symptomatic (Pediatric Eosinophilic Esophagitis Symptom Severity Module v2.0: PEESS) and quality of life (Peds-QL EoE Module 1) outcomes of DED and FREE in children with eosinophilic esophagitis

The investigators plan to enroll 72 patients over 4 sites each enrolling 18 patients per site in a 16-month period (approximately 1 patient per month per site) having 9 patients per site in each group (DED and FREE).

The investigators will enroll patients > 5- <17 years of age with isolated esophageal eosinophilia (>15 eos/hpf). Patients with food impaction, peripheral eosinophilia > 1,500 µL , concomitant GI inflammatory conditions, history of upper GI tract surgery (e.g. fundoplication), acid reflux by pH probe, anaphylactic food allergies, severe developmental delay, taking recently prescribed inhaled corticosteroids or oral corticosteroids, have other medical conditions likely interfere with the study, has a significant psychiatric condition, has taken a PPI in the last 4 weeks, has taken swallowed steroids in the last 12 weeks, or are not fluent in spoken and written English will be excluded.

Participants will be enrolled at: Nemours Children's Hospital, Orlando, FL; Alfred I Dupont Hospital, Wilmington, DE; Seattle Children's Hospital, Seattle, WA

Once eligibility criteria are met, participants will be randomized to DED or FREE study groups. Participants will receive dietary education. Lead dietitians from each site will be identified and the approaches to dietary education will be standardized. Dietary education will be completed at the baseline visit and during follow up phone calls throughout the study.Each participant will complete all study visits in 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, prospective, parallel
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Food Additive Removal Diet for Pediatric Eosinophilic Esophagitis
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: DED
Diet eliminating dairy
Other: DED
DED: Diet eliminating dairy

Active Comparator: FREE
Diet eliminating dairy and food additives
Other: FREE
FREE: Diet eliminating dairy and food additives




Primary Outcome Measures :
  1. Eosinophils Per High Power Field (eos/hpf) [ Time Frame: 12 weeks ]
    Histologic change differences of maximum eosinophils per high power field


Secondary Outcome Measures :
  1. Eosinophilic Esophagitis Endoscopic Reference Score (EREFS) [ Time Frame: 12 weeks ]
    An endoscopic outcome measure to follow response to treatment. Scores range from 0 to 15 with higher scores indicating more endoscopic evidence of eosinophilic esophagitis.


Other Outcome Measures:
  1. Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS) [ Time Frame: Baseline, 4, 8, and 12 weeks ]
    Self report measure of symptoms associated with eosinophilic esophagitis. Scores range from 0 to 100. The higher the score, the more frequent and severe the symptoms.

  2. Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS): Parent Report [ Time Frame: Baseline, 4, 8, and 12 weeks ]
    Parent report measure of symptoms associated with eosinophilic esophagitis. Scores range from 0 to 100. The higher the score, the more frequent and severe the symptoms.

  3. Pediatric Quality of Life Inventory: Eosinophilic Esophagitis Module (PedsQL-EoE) [ Time Frame: Baseline, 4, 8, and 12 weeks ]
    Self report measure of quality of life and symptoms associated with eosinophilic esophagitis. This measure has several subscales (Symptoms I, Symptoms II, Treatment, Worry, Communication, Food and Eating, Food Feelings) that produce scaled scores ranging from 0 to 100. The total scaled score also ranges from 0 to 100. A higher score indicates better quality of life.

  4. Pediatric Quality of Life Inventory: Eosinophilic Esophagitis Module (PedsQL-EoE): Parent Report [ Time Frame: Baseline, 4, 8, and 12 weeks ]
    Parent report measure of quality of life and symptoms associated with eosinophilic esophagitis. This measure has several subscales (Symptoms I, Symptoms II, Treatment, Worry, Communication, Food and Eating, Food Feelings) that produce scaled scores ranging from 0 to 100. The total scaled score also ranges from 0 to 100. A higher score indicates better quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. An Institutional Review Board (IRB) approved written Parental Permission form is signed and dated by the parent or legal representative/caregiver.
  2. If applicable, an Institutional Review Board (IRB) approved written Assent form is signed and dated by the participant.
  3. The participant/parent(s) or legal representative(s)/caregiver(s) are considered reliable and capable of adhering to the protocol call schedule and dietary requirements.
  4. The participant is >2 years to <18 years of age.
  5. The participant has isolated esophageal eosinophilia (>15 eos/hpf).
  6. The family has access to the internet to complete weekly surveys and to a telephone to complete weekly follow up calls.
  7. The biopsy used to diagnose eosinophilic esophagitis was taken no more than 12 weeks prior to the date of enrollment.

Exclusion Criteria:

  1. The participant has peripheral eosinophilia > 1,500 µL
  2. The participant has concomitant GI inflammatory conditions (e.g. celiac disease, inflammatory bowel disease).
  3. The participant has a history of upper GI tract surgery (e.g. fundoplication)
  4. Acid reflux by pH probe is suggested (*A pH probe is not required, but may be done as standard of care)
  5. The participant has severe developmental delay that, in the opinion of the investigator, could jeopardize the participant's ability to participate in the study.
  6. The participant has taken prednisone in the last 12 weeks, or has taken fluticasone or budesonide in the last 8 weeks.
  7. The participant has other significant medical conditions that, in the opinion of the provider, would impact the participant's ability to participate in the study.
  8. The participant has a psychiatric condition that, in the opinion of the investigator, could jeopardize the participant's ability to participate in the study.
  9. The participant does not speak or read English fluently.
  10. The participant is currently taking a PPI (If discontinued, no washout required.)
  11. The participant is currently on or previously failed a dairy free diet for EoE.

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): NCT03657771


Contacts
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Contact: Shannon J Henry, MA 407-650-7713 shannon.henry@nemours.org

Locations
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United States, Delaware
Nemours/Alfred I DuPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19083
Contact: Zarela Molle-Rios, MD    302-651-5928    zarela.mollerios@nemours.org   
Sub-Investigator: Zarela Molle-Rios, MD         
United States, Florida
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: James P Franciosi, MD    407-567-3832    james.franciosi@nemours.org   
Contact: Shannon J Henry, MA    407-650-7713    shannon.henry@nemours.org   
Principal Investigator: James P Franciosi, MD         
United States, Washington
Seattle Children's Hospital Not yet recruiting
Seattle, Washington, United States, 98105
Contact: David Suskind, MD    206-987-2521    david.suskind@seattlechildrens.org   
Contact: Madeline Ford    206-884-7426    Madeline.Ford@seattlechildrens.org   
Sub-Investigator: David Suskind, MD         
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
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Principal Investigator: James P Franciosi, MD Nemours Children's Clinic
  Study Documents (Full-Text)

Documents provided by James Franciosi, Nemours Children's Clinic:
Informed Consent Form  [PDF] July 27, 2020

Publications:

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Responsible Party: James Franciosi, Chief, Division of Gastroenterology, Hepatology and Nutrition, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT03657771    
Other Study ID Numbers: 1173700
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 James Franciosi, Nemours Children's Clinic:
Esophagitis
Diet
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases