SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study

Phase 2/3 Completed 129 enrolled Children's Hospital Medical Center, Cincinnati National Center for Advancing Translational Sciences (NCATS) · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab Office of Rare Diseases (ORD) · collab

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this interventional study is to test and compare the effectiveness of two elimination diets-the 1-food elimination diet (1FED, milk only) and the 6-food elimination diet (6FED, milk, egg, wheat, soy, tree nut/peanuts, and fish/shellfish). The study will also test the effectiveness of swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was not effective.

Timeline

Start: 2016-05-20
Primary completion: 2019-04-17
Completion: 2019-05-29

Outcome

Missed primary endpoint

registry analysis (other test); 1-Food Elimination Diet (1FED) vs 6-Food Elimination Diet (6FED); p = 0.58; Fisher Exact; note: α < 0.05 NCT02778867 ↗

paper At 6 weeks, 25 (40%) of 62 patients in the 6FED group had histological remission compared with 23 (34%) of 67 in the 1FED group (difference 6% [95% CI -11 to 23]; p=0·58). PMID 36863390 ↗

Publications

Kliewer KL, Gonsalves N, Dellon ES, Katzka DA, Abonia JP, Aceves SS, Arva NC, Besse JA, Bonis PA, Caldwell JM, Capocelli KE, Chehade M, Cianferoni A, Collins MH, Falk GW, Gupta SK, Hirano I, Krischer JP, Leung J, Martin LJ, Menard-Katcher P, Mukkada VA, Peterson KA, Shoda T, Rudman Spergel AK, Spergel JM, Yang GY, Zhang X, Furuta GT, Rothenberg ME. One-food versus six-food elimination diet therapy for the treatment of eosinophilic oesophagitis: a multicentre, randomised, open-label trial. Lancet Gastroenterol Hepatol. 2023 May;8(5):408-421. doi: 10.1016/S2468-1253(23)00012-2. Epub 2023 Feb 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone propionate	Other / unclassified	880 ug	Oral