One-food versus 4-food elimination diet for pediatric eosinophilic esophagitis: A multisite randomized trial - 24/09/24

Doi : 10.1016/j.jaci.2024.08.023

Kara L. Kliewer, PhD ^a, J. Pablo Abonia, MD ^a, Seema S. Aceves, MD, PhD ^b, Dan Atkins, MD ^c, Peter A. Bonis, MD ^d, Kelley E. Capocelli, MD ^e, Mirna Chehade, MD ^f, Margaret H. Collins, MD ^g, Evan S. Dellon, MD ^h, Lin Fei, PhD ⁱ, Glenn T. Furuta, MD ^j, Sandeep K. Gupta, MD ^k, Amir Kagalwalla, MD ^l, John Leung, MD ^m, Sabina Mir, MD ⁿ, Vincent A. Mukkada, MD ^o, Robbie Pesek, MD ^p, Chen Rosenberg, MD ^a, Tetsuo Shoda, MD, PhD ^a, Jonathan M. Spergel, MD, PhD ^q, Qin Sun, MS ⁱ, Joshua B. Wechsler, MD, MS ^l, Guang-Yu Yang, MD ^r, Marc E. Rothenberg, MD, PhD ^a,^⁎
^a Division of Allergy and Immunology, Department of Pediatrics Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio
^b Division of Allergy and Immunology, University of California, San Diego, Rady Children’s Hospital, San Diego, Calif
^c Section of Allergy and Immunology, Children’s Hospital Colorado, Aurora, Colo
^d Division of Gastroenterology, Tufts Medical Center, Boston, Mass
^e Department of Pathology, Children’s Hospital Colorado, Aurora, Colo
^f Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai, New York, NY
^g Division of Pathology and Laboratory Medicine, Cincinnati Children’s Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio
^h Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC
ⁱ Division of Biostatistics and Epidemiology, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio
^j Section of Pediatric Gastroenterology, Hepatology and Nutrition, Children’s Hospital Colorado, Aurora, Colo
^k Division of Pediatric Gastroenterology, Hepatology and Nutrition, Indiana University School of Medicine, Riley Hospital for Children, Indianapolis, Ind
^l Division of Gastroenterology, Hepatology and Nutrition, Ann and Robert H. Lurie Children’s Hospital of Chicago, Chicago, Ill
^m Boston Specialists, Boston, Mass
ⁿ Division of Gastroenterology, Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC
^o Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children’s Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio
^p University of Arkansas Medical School, Little Rock, Ark
^q Division of Allergy and Immunology, Children’s Hospital of Philadelphia, Perelman School of Medicine at University of Pennsylvania, Philadelphia, Pa
^r Department of Pathology, Northwestern University Feinberg School of Medicine, Chicago, Ill

^∗Corresponding author: Marc E. Rothenberg, MD, PhD, Division of Allergy and Immunology, Cincinnati Children’s Hospital Medical Center, MLC 7028, 3333 Burnet Ave, Cincinnati, OH 45229.Division of Allergy and ImmunologyCincinnati Children’s Hospital Medical CenterMLC 70283333 Burnet AveCincinnatiOH45229

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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.

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Key words : Eosinophilic esophagitis, elimination diet, comparative effectiveness, quality of life, milk

Abbreviations used : BMI, CI, DMCC, EDP, EoE, eos/hpf, EREFS, FED, HSS, PedsQL, PEESS, PROMIS, QoL, SD, SE, SGC, sIgE, sIgG₄, SPT

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One-food versus 4-food elimination diet for pediatric eosinophilic esophagitis: A multisite randomized trial - 24/09/24

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Abstract

Background

Objective

Methods

Results

Conclusions

Plan

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