One-food versus 4-food elimination diet for pediatric eosinophilic esophagitis: A multisite randomized trial

Kara L Kliewer; J Pablo Abonia; Seema S Aceves; Dan Atkins; Peter A Bonis; Kelley E Capocelli; Mirna Chehade; Margaret H Collins; Evan S Dellon; Lin Fei; Glenn T Furuta; Sandeep K Gupta; Amir Kagalwalla; John Leung; Sabina Mir; Vincent A Mukkada; Robbie Pesek; Chen Rosenberg; Tetsuo Shoda; Jonathan M Spergel; Qin Sun; Joshua B Wechsler; Guang-Yu Yang; Marc E Rothenberg

doi:10.1016/j.jaci.2024.08.023

One-food versus 4-food elimination diet for pediatric eosinophilic esophagitis: A multisite randomized trial

J Allergy Clin Immunol. 2024 Sep 2:S0091-6749(24)00907-2. doi: 10.1016/j.jaci.2024.08.023. Online ahead of print.

Authors

Kara L Kliewer¹, J Pablo Abonia¹, Seema S Aceves², Dan Atkins³, Peter A Bonis⁴, Kelley E Capocelli⁵, Mirna Chehade⁶, Margaret H Collins⁷, Evan S Dellon⁸, Lin Fei⁹, Glenn T Furuta¹⁰, Sandeep K Gupta¹¹, Amir Kagalwalla¹², John Leung¹³, Sabina Mir¹⁴, Vincent A Mukkada¹⁵, Robbie Pesek¹⁶, Chen Rosenberg¹, Tetsuo Shoda¹, Jonathan M Spergel¹⁷, Qin Sun⁹, Joshua B Wechsler¹², Guang-Yu Yang¹⁸, Marc E Rothenberg¹⁹

Affiliations

¹ Division of Allergy and Immunology, Department of Pediatrics Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.
² Division of Allergy and Immunology, University of California, San Diego, Rady Children's Hospital, San Diego, Calif.
³ Section of Allergy and Immunology, Children's Hospital Colorado, Aurora, Colo.
⁴ Division of Gastroenterology, Tufts Medical Center, Boston, Mass.
⁵ Department of Pathology, Children's Hospital Colorado, Aurora, Colo.
⁶ Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai, New York, NY.
⁷ Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio.
⁸ Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC.
⁹ Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
¹⁰ Section of Pediatric Gastroenterology, Hepatology and Nutrition, Children's Hospital Colorado, Aurora, Colo.
¹¹ Division of Pediatric Gastroenterology, Hepatology and Nutrition, Indiana University School of Medicine, Riley Hospital for Children, Indianapolis, Ind.
¹² Division of Gastroenterology, Hepatology and Nutrition, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.
¹³ Boston Specialists, Boston, Mass.
¹⁴ Division of Gastroenterology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC.
¹⁵ Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio.
¹⁶ University of Arkansas Medical School, Little Rock, Ark.
¹⁷ Division of Allergy and Immunology, Children's Hospital of Philadelphia, Perelman School of Medicine at University of Pennsylvania, Philadelphia, Pa.
¹⁸ Department of Pathology, Northwestern University Feinberg School of Medicine, Chicago, Ill.
¹⁹ Division of Allergy and Immunology, Department of Pediatrics Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio. Electronic address: [email protected].

PMID: 39233016
DOI: 10.1016/j.jaci.2024.08.023

Abstract

Background: A 6-food elimination diet in pediatric eosinophilic esophagitis (EoE) is difficult to implement and may negatively affect quality of life (QoL). Less restrictive elimination diets may balance QoL and efficacy.

Objective: We performed a multisite, randomized comparative efficacy trial of a 1-food (milk) elimination diet (1FED) versus 4-food (milk, egg, wheat, soy) elimination diet (4FED) in pediatric EoE.

Methods: Patients aged 6 to 17 years with histologically active and symptomatic EoE were randomized 1:1 to 1FED or 4FED for 12 weeks. Primary end point was symptom improvement by Pediatric Eosinophilic Esophagitis Symptom Score (PEESS). Secondary end points were proportion experiencing histologic remission (<15 eosinophils per high-power field); change in histologic features (histology scoring system), endoscopic severity (endoscopic reference score), transcriptome (EoE diagnostic panel), and QoL scores; and predictors of remission.

Results: Sixty-three patients were randomly assigned to 1FED (n = 38) and 4FED (n = 25). In 4FED versus 1FED, mean PEESS improved -25.0 versus -14.5 (P = .04), but remission rates (41% vs 44%; P = 1.00), histology scoring system (-0.25 vs -0.29; P = .77), endoscopic reference score (-1.10 vs -0.58; P = .47), and QoL scores were similar between groups. The EoE transcriptome normalized in those with histologic response to both diets. Baseline peak eosinophil count predicted remission (odds ratio, 0.975 [95% confidence interval, 0.953-0.999], P = .04; cutoff ≤42 eosinophils per high-power field). The 4FED withdrawal rate (32%) exceeded that of 1FED (11%) (P = .0496).

Conclusions: Although 4FED moderately improved symptoms compared with 1FED, the histologic, endoscopic, QoL, and transcriptomic outcomes were similar in both groups. 1FED is a reasonable first-choice therapy for pediatric EoE, given its effects, tolerability, and relative simplicity.

Keywords: Eosinophilic esophagitis; comparative effectiveness; elimination diet; milk; quality of life.