A Food Additive Removal Diet for Pediatric Eosinophilic Esophagitis (FREE)
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|ClinicalTrials.gov Identifier: NCT03657771|
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis||Other: DED Other: FREE||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, prospective, parallel|
|Masking:||None (Open Label)|
|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|
Active Comparator: DED
Diet eliminating dairy
DED: Diet eliminating dairy
Active Comparator: FREE
Diet eliminating dairy and food additives
FREE: Diet eliminating dairy and food additives
- Eosinophils Per High Power Field (eos/hpf) [ Time Frame: 12 weeks ]Histologic change differences of maximum eosinophils per high power field
- 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.
- 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.
- 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.
- 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.
- 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
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
|Contact: Shannon J Henry, MAemail@example.com|
|United States, Delaware|
|Nemours/Alfred I DuPont Hospital for Children||Recruiting|
|Wilmington, Delaware, United States, 19083|
|Contact: Zarela Molle-Rios, MD 302-651-5928 firstname.lastname@example.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 email@example.com|
|Contact: Shannon J Henry, MA 407-650-7713 firstname.lastname@example.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 email@example.com|
|Contact: Madeline Ford 206-884-7426 Madeline.Ford@seattlechildrens.org|
|Sub-Investigator: David Suskind, MD|
|Principal Investigator:||James P Franciosi, MD||Nemours Children's Clinic|