Esophagus to Small Intestine

Lancet Gastroenterol Hepatol. 2023;8(5):408−21

Kliewer KL, Gonsalves N, Dellon ES, Katzka DA, Abonia JP, Aceves SS, Arva NC, Besse JA, Bonis PA, Caldwell JM, Capocelli KE, Chehade M, Cianfer-oni 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

1-food versus 6-food elimination diet therapy for the treatment of eosinophilic esophagitis: A multicenter, ran-domized, open-label trial

Background: Empirical elimination diets are effective for achieving histological remission in eosinophilic esophagitis (EoE), but randomized trials comparing diet therapies are lacking. The authors aimed to compare a 6-food elimination diet (6-FED) with a 1-food elimination diet (1-FED) for the treatment of adults with EoE.
Methods: They conducted a multicenter, randomized, open-label trial across 10 sites of the Consortium of Eosinophilic Gastrointestinal Disease Researchers in the USA. Adults aged 18−60 years with active, symptomatic EoE were centrally randomly allocated (1:1; block size of 4) to 1-FED (animal milk) or 6-FED (animal milk, wheat, egg, soy, fish and shellfish, and peanut and tree nuts) for 6 weeks. Randomization was stratified by age, enrolling site, and gender. The primary end point was the proportion of patients with histological remission (peak esophageal count < 15 eosinophils per high-power field [eos/hpf]). Key secondary end points were the proportions with complete histological remission (peak count ≤ 1 eos/hpf) and partial remission (peak counts ≤ 10 and ≤ 6 eos/hpf) and changes from baseline in peak eosinophil count and scores on the Eosino-philic Esophagitis Histology Scoring System (EoEHSS), Eosinophilic Esophagitis Endoscopic Reference Score (EREFS), Eosinophilic Esophagitis Activ-ity Index (EEsAI), and quality of life (Adult Eosinophilic Esophagitis Quality-of-Life and Patient Reported Outcome Measurement Information System Global Health questionnaires). Individuals without histological response to 1-FED could proceed to 6-FED, and those without histological response to 6-FED could proceed to swallowed topical fluticasone propionate 880 μg twice per day (with unrestricted diet), for 6 weeks. Histo-logical remission after switching therapy was assessed as a secondary end point. Efficacy and safety analyses were done in the intention-to-treat (ITT) population.
Findings: Between May 23, 2016, and March 6, 2019, 129 patients (70 men [54%] and 59 women [46%]; mean age 37.0 years [SD 10.3]) were enrolled, randomly assigned to 1-FED (n = 67) or 6-FED (n = 62), and included in the ITT population. At 6 weeks, 25 of 62 patients (40%) in the 6-FED group had histological remission compared with 23 of 67 (34%) in the 1-FED group (difference, 6% [95% confidence interval: -11−23]; p = 0.58). The authors found no significant difference between the groups at stricter thresholds for partial remission (≤ 10 eos/hpf, difference, 7% [-9−24], p = 0.46; ≤ 6 eos/hpf, 14% [-0−29], p = 0.069); the proportion with complete remission was significantly higher in the 6-FED group than in the 1-FED group (difference, 13% [2−25]; p = 0.031). Peak eosinophil counts decreased in both groups (geometric mean ratio = 0.72 [0.43−1.20]; p = 0.21). For 6-FED versus 1-FED, mean changes from baseline in EoEHSS (-0.23 vs. -0.15; difference, -0.08 [-0.21−0.05]; p = 0.23), EREFS (-1.0 vs. -0.6; difference, -0.4 [-1.1−0.3]; p = 0.28), and EEsAI (-8.2 vs. -3.0; difference, -5.2 [-11.2−0.8]; p = 0.091) were not significantly different. Changes in quality-of-life scores were small and similar between the groups. No adverse event was observed in more than 5% of pa-tients in either diet group. For patients without histological response to 1-FED who proceeded to 6-FED, 9 of 21 (43%) reached histological remis-sion; for patients without histological response to 6-FED who proceeded to fluticasone propionate, 9 of 11 (82%) reached histological remission.

Interpretation: Histological remission rates and improvements in histological and endoscopic features were similar after a 1-food elimination diet (1-FED) and a 6-food elimination diet (6-FED) in adults with eosinophilic esophagitis (EoE). 6-FED had efficacy in just less than half of 1-FED non-responders and steroids had efficacy in most 6-FED non-responders. The findings indicate that eliminating animal milk alone is an acceptable initial dietary therapy for EoE.

M.E. Rothenberg, M.D., Ph.D., Professor of Medicine, Division of Allergy and Immunology, Department of Pediatrics, Cincinnati Children’s Hospi-tal Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA,

DOI: 10.1016/s2468-1253(23)00012-2

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