A Food Additive Removal Diet for Pediatric Eosinophilic Esophagitis

NCT03657771 | Completed

• 1 other identifier: 1173700
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

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)

Conditions

Eosinophilic Esophagitis

Keywords

Esophagitis; Diet

Outcome Measures

Primary Outcomes (1)

• Eosinophils Per High Power Field (eos/hpf)

  Histologic change differences of maximum eosinophils per high power field

  12 weeks

Secondary Outcomes (1)

• Eosinophilic Esophagitis Endoscopic Reference Score (EREFS)

  12 weeks

Other Outcomes (4)

• Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS)

  Baseline, 4, 8, and 12 weeks

• Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS): Parent Report

  Baseline, 4, 8, and 12 weeks

• Pediatric Quality of Life Inventory: Eosinophilic Esophagitis Module (PedsQL-EoE)

  Baseline, 4, 8, and 12 weeks

Study Arms (2)

DED

ACTIVE COMPARATOR

Diet eliminating dairy

Other: DED

FREE

ACTIVE COMPARATOR

Diet eliminating dairy and food additives

Other: FREE

Interventions

DED OTHER

DED: Diet eliminating dairy

DED

FREE OTHER

FREE: Diet eliminating dairy and food additives

FREE

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• An Institutional Review Board (IRB) approved written Parental Permission form is signed and dated by the parent or legal representative/caregiver.
• If applicable, an Institutional Review Board (IRB) approved written Assent form is signed and dated by the participant.
• 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.
• The participant is \>2 years to \<18 years of age.
• The participant has isolated esophageal eosinophilia (\>15 eos/hpf).
• The family has access to the internet to complete weekly surveys and to a telephone to complete weekly follow up calls.
• The biopsy used to diagnose eosinophilic esophagitis was taken no more than 12 weeks prior to the date of enrollment.

You may not qualify if:

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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (3)

Nemours/Alfred I DuPont Hospital for Children

Wilmington, Delaware, 19083, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (12)

• Franciosi JP, Hommel KA, Bendo CB, King EC, Collins MH, Eby MD, Marsolo K, Abonia JP, von Tiehl KF, Putnam PE, Greenler AJ, Greenberg AB, Bryson RA, Davis CM, Olive AP, Gupta SK, Erwin EA, Klinnert MD, Spergel JM, Denham JM, Furuta GT, Rothenberg ME, Varni JW. PedsQL eosinophilic esophagitis module: feasibility, reliability, and validity. J Pediatr Gastroenterol Nutr. 2013 Jul;57(1):57-66. doi: 10.1097/MPG.0b013e31828f1fd2.

  PMID: 23478422 BACKGROUND

• Martino JV, Van Limbergen J, Cahill LE. The Role of Carrageenan and Carboxymethylcellulose in the Development of Intestinal Inflammation. Front Pediatr. 2017 May 1;5:96. doi: 10.3389/fped.2017.00096. eCollection 2017.

  PMID: 28507982 BACKGROUND

• Dellon ES, Jensen ET, Martin CF, Shaheen NJ, Kappelman MD. Prevalence of eosinophilic esophagitis in the United States. Clin Gastroenterol Hepatol. 2014 Apr;12(4):589-96.e1. doi: 10.1016/j.cgh.2013.09.008. Epub 2013 Sep 11.

  PMID: 24035773 BACKGROUND

• Dellon ES, Gonsalves N, Hirano I, Furuta GT, Liacouras CA, Katzka DA; American College of Gastroenterology. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). Am J Gastroenterol. 2013 May;108(5):679-92; quiz 693. doi: 10.1038/ajg.2013.71. Epub 2013 Apr 9.

  PMID: 23567357 BACKGROUND

• Imam T, Gupta SK. Topical glucocorticoid vs. diet therapy in eosinophilic esophagitis: the need for better treatment options. Expert Rev Clin Immunol. 2016 Aug;12(8):797-9. doi: 10.1080/1744666X.2016.1191947. Epub 2016 Jun 13. No abstract available.

  PMID: 27206496 BACKGROUND

• Kagalwalla AF, Wechsler JB, Amsden K, Schwartz S, Makhija M, Olive A, Davis CM, Manuel-Rubio M, Marcus S, Shaykin R, Sulkowski M, Johnson K, Ross JN, Riffle ME, Groetch M, Melin-Aldana H, Schady D, Palac H, Kim KA, Wershil BK, Collins MH, Chehade M. Efficacy of a 4-Food Elimination Diet for Children With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2017 Nov;15(11):1698-1707.e7. doi: 10.1016/j.cgh.2017.05.048. Epub 2017 Jun 8.

  PMID: 28603055 BACKGROUND

• Newberry C, Lynch K. Can We Use Diet to Effectively Treat Esophageal Disease? A Review of the Current Literature. Curr Gastroenterol Rep. 2017 Aug;19(8):38. doi: 10.1007/s11894-017-0578-5.

  PMID: 28730507 BACKGROUND

• Groetch M, Venter C, Skypala I, Vlieg-Boerstra B, Grimshaw K, Durban R, Cassin A, Henry M, Kliewer K, Kabbash L, Atkins D, Nowak-Wegrzyn A, Holbreich M, Chehade M; Eosinophilic Gastrointestinal Disorders Committee of the American Academy of Allergy, Asthma and Immunology. Dietary Therapy and Nutrition Management of Eosinophilic Esophagitis: A Work Group Report of the American Academy of Allergy, Asthma, and Immunology. J Allergy Clin Immunol Pract. 2017 Mar-Apr;5(2):312-324.e29. doi: 10.1016/j.jaip.2016.12.026.

  PMID: 28283156 BACKGROUND

• Kagalwalla AF, Sentongo TA, Ritz S, Hess T, Nelson SP, Emerick KM, Melin-Aldana H, Li BU. Effect of six-food elimination diet on clinical and histologic outcomes in eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1097-102. doi: 10.1016/j.cgh.2006.05.026. Epub 2006 Jul 21.

  PMID: 16860614 BACKGROUND

• Gonsalves N, Yang GY, Doerfler B, Ritz S, Ditto AM, Hirano I. Elimination diet effectively treats eosinophilic esophagitis in adults; food reintroduction identifies causative factors. Gastroenterology. 2012 Jun;142(7):1451-9.e1; quiz e14-5. doi: 10.1053/j.gastro.2012.03.001. Epub 2012 Mar 3.

  PMID: 22391333 BACKGROUND

• Suskind DL, Wahbeh G, Gregory N, Vendettuoli H, Christie D. Nutritional therapy in pediatric Crohn disease: the specific carbohydrate diet. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):87-91. doi: 10.1097/MPG.0000000000000103.

  PMID: 24048168 BACKGROUND

• Collins MH, Martin LJ, Alexander ES, Boyd JT, Sheridan R, He H, Pentiuk S, Putnam PE, Abonia JP, Mukkada VA, Franciosi JP, Rothenberg ME. Newly developed and validated eosinophilic esophagitis histology scoring system and evidence that it outperforms peak eosinophil count for disease diagnosis and monitoring. Dis Esophagus. 2017 Feb 1;30(3):1-8. doi: 10.1111/dote.12470.

  PMID: 26857345 BACKGROUND

MeSH Terms

Conditions

Eosinophilic Esophagitis; Esophagitis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Edward B. Mougey, PhD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Randomized, prospective, parallel

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 5, 2018
• Study Start: November 12, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)