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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4, 8, and 12 weeks for reporting.

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 more

FREE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor

124 Previous Clinical Trials

18,109 Total Patients Enrolled

James P Franciosi, MDPrincipal InvestigatorNemours Children's Clinic

2 Previous Clinical Trials

213 Total Patients Enrolled

Media Library

DED (Dietary Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03657771 — N/A

Eosinophilic Esophagitis Research Study Groups: DED, FREE

Eosinophilic Esophagitis Clinical Trial 2023: DED Highlights & Side Effects. Trial Name: NCT03657771 — N/A

DED (Dietary Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03657771 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is able to join this clinical exploration?

"This study is seeking 72 individuals aged 2 to 18 with a diagnosis of eosinophilic esophagitis. Applicants must also satisfy the following criteria: completion and submission of an Institutional Review Board (IRB) approved parental permission form, access to internet for weekly surveys and telephone calls, isolated esophageal eosinophilia (>15eos/hpf), biopsy taken within 12 weeks prior to enrollment date, and assurance that parent(s)/caregiver are reliable in adhering to protocol call schedule and dietary requirements."

Answered by AI

Could you provide a figure for the aggregate of participants in this research project?

"Correct. According to the information featured on clinicaltrials.gov, this medical trial is currently accepting participants and was first posted in November 2018 with its last update occurring in April 2022. 72 patients are needed from 3 different sites for enrollment into the study."

Answered by AI

Is this experiment recruiting participants older than thirty-five years of age?

"This trial only operates with patients that are between 2 and 18 years old. There are 26 studies available for minors while 37 apply to those aged 65 or older."

Answered by AI

Is this scientific experiment actively searching for new participants?

"Affirmative. Evidence on clinicaltrials.gov confirms that this research is currently accepting participants, with recruitment beginning on November 12th 2018 and last updated April 7th 2022. 72 individuals are required to partake in the trial across 3 locations."

Answered by AI

Recent research and studies

Clinical Gastroenterology and HepatologyJournal

Prevalence of Eosinophilic Esophagitis in the United States

Dellon, Evan S., Elizabeth T. Jensen, Christopher F. Martin, Nicholas J. Shaheen, and Michael D. Kappelman. 2014. “Prevalence of Eosinophilic Esophagitis in the United States”. Clinical Gastroenterology and Hepatology. Elsevier BV. doi:10.1016/j.cgh.2013.09.008.

Current Gastroenterology ReportsJournal

Can We Use Diet to Effectively Treat Esophageal Disease? A Review of the Current Literature

Newberry, Carolyn, and Kristle Lynch. 2017. “Can We Use Diet to Effectively Treat Esophageal Disease? A Review of the Current Literature”. Current Gastroenterology Reports. Springer Science and Business Media LLC. doi:10.1007/s11894-017-0578-5.

GastroenterologyJournal

Elimination Diet Effectively Treats Eosinophilic Esophagitis in Adults; Food Reintroduction Identifies Causative Factors

Gonsalves, Nirmala, Guang–Yu Yang, Bethany Doerfler, Sally Ritz, Anne M. Ditto, and Ikuo Hirano. 2012. “Elimination Diet Effectively Treats Eosinophilic Esophagitis in Adults; Food Reintroduction Identifies Causative Factors”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2012.03.001.

Diseases of the EsophagusJournal