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Dietary Therapy
Dietary Approaches for Eosinophilic Esophagitis (FREE Trial)
N/A
Waitlist Available
Led By James P Franciosi, MD
Research Sponsored by Nemours Children's Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4, 8, and 12 weeks
Awards & highlights
FREE Trial Summary
This trial looks at whether two different dietary approaches can help people with eczema.
Who is the study for?
This trial is for children and teens aged 2 to under 18 with Eosinophilic Esophagitis, who can follow the diet plan and survey schedule. They must have internet access, no severe allergies or GI conditions like celiac disease, haven't had upper GI surgery, aren't on certain medications recently (like PPIs), and haven't tried a dairy-free diet for EoE before.Check my eligibility
What is being tested?
The study compares two diets in treating pediatric Eosinophilic Esophagitis: one group will avoid only dairy (DED), while the other will eliminate both dairy and food additives (FREE). It's a head-to-head test to see which diet works better.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include nutritional deficiencies or reactions related to dietary adjustments. Specific side effects are not listed but monitoring overall health is important.
FREE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4, 8, and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4, 8, and 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Eosinophil
Secondary outcome measures
Eosinophilic Esophagitis Endoscopic Reference Score (EREFS)
Other outcome measures
Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS)
Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS): Parent Report
Pediatric Quality of Life Inventory: Eosinophilic Esophagitis Module (PedsQL-EoE)
+1 moreFREE Trial Design
2Treatment groups
Active Control
Group I: DEDActive Control1 Intervention
Diet eliminating dairy
Group II: FREEActive Control1 Intervention
Diet eliminating dairy and food additives
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Who is running the clinical trial?
Nemours Children's ClinicLead Sponsor
125 Previous Clinical Trials
18,145 Total Patients Enrolled
James P Franciosi, MDPrincipal InvestigatorNemours Children's Clinic
2 Previous Clinical Trials
213 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a digestive system condition that causes inflammation such as celiac disease or inflammatory bowel disease.You have symptoms of acid reflux, which may be confirmed by a test called pH probe.You have other health problems that could prevent you from taking part in the study, according to your doctor's judgment.You have a mental health condition that may affect your ability to take part in the study, according to the investigator's opinion.You are not able to understand and communicate fluently in English.You have taken prednisone within the last 12 weeks or fluticasone/budesonide within the last 8 weeks.You are currently following or have tried a dairy-free diet for Eosinophilic Esophagitis (EoE).
Research Study Groups:
This trial has the following groups:- Group 1: DED
- Group 2: FREE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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