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A Food Additive Removal Diet for Pediatric Eosinophilic Esophagitis
Prospective, pragmatic standard of care clinical trial comparing dietary therapies of standard four food elimination diet alone (4FED; milk, soy, wheat and eggs) to four food elimination plus food additive elimination (4FED+FREE)
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
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|Eligible Ages||5 Years - 16 Years|
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 >5 years to <17 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.
Exclusion Criteria:1. The participant has food impaction. 2. The participant has peripheral eosinophilia > 1,500 µL 3. The participant has concomitant GI inflammatory conditions (e.g. celiac disease, inflammatory bowel disease). 4. The participant has a history of upper GI tract surgery (e.g. fundoplication) 5. Acid reflux by pH probe is suggested (*A pH probe is not required, but may be done as standard of care) 6. The participant has anaphylactic food allergies. 7. The participant has severe developmental delay that, in the opinion of the investigator, could jeopardize the participant's ability to participate in the study. 8. The participant is taking inhaled corticosteroids or oral corticosteroids for asthma, or has taken them in the last two months. 9. 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. 10. The participant has a psychiatric condition that, in the opinion of the investigator, could jeopardize the participant's ability to participate in the study. 11. The participant does not speak or read English fluently. 12. The participant has taken a PPI in the last 4 weeks. 13. The participant has taken a swallowed steroid in the last 12 weeks.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Nemours Children's Clinic|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|James P Franciosi, MD|
|Principal Investigator Affiliation||Nemours Children's Clinic|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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 allergens most likely to evoke the inflammatory response. Primary Objective: To compare histologic outcomes (eosinophils per high power field: eos/hpf) of 4FED+FREEand 4FED in children with eosinophilic esophagitis. Secondary Objective: To compare endoscopic outcomes (Eosinophilic Esophagitis Endoscopic Reference scores: EREFs) of 4FED+FREE and 4FED 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 4FED+FREE and 4FED in children with eosinophilic esophagitis We will 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 (4FED+FREE and 4FED). We 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 patients meet eligibility criteria, they will be randomized to 4FED or 4FED+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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