Prospective study of an amino acid–based elemental diet in an eosinophilic gastritis and gastroenteritis nutrition trial

• Published in: Journal of allergy and clinical immunology Vol. 152; no. 3; pp. 676 - 688
• Main Authors: Gonsalves, Nirmala, Doerfler, Bethany, Zalewski, Angelika, Yang, Guang-Yu, Martin, Lisa J., Zhang, Xue, Shoda, Tetsuo, Brusilovsky, Michael, Aceves, Seema, Thompson, Kathy, Rudman Spergel, Amanda K., Furuta, Glenn, Rothenberg, Marc E., Hirano, Ikuo
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2023
• Subjects: Adult; Allergens - therapeutic use; Amino Acids; elemental diet; Enteritis - pathology; eosinophilia; Eosinophilia - drug therapy; Eosinophilic Esophagitis; Eosinophilic gastritis; eosinophilic gastroenteritis; Female; food allergy; Food Hypersensitivity; Food, Formulated; Gastroenteritis; Humans; Male; Prospective Studies; Quality of Life; EoGE; Eosinophilic gastritis; PRO; EGDP; Ct; OTU; PhGA; eosinophilia; EGID; CEGIR; EGD; TSLP; PROMIS; SOC; EGHSS; elemental diet; food allergy; eosinophilic gastroenteritis; EGREFS; QOL; eos/hpf; TARC; EoE; EoG; ELE; SODA
• ISSN: 0091-6749; 1097-6825; 1097-6825
• DOI: 10.1016/j.jaci.2023.05.024

[Display omitted] Eosinophilic gastritis/gastroenteritis (EoG/EoGE) are rare disorders with pathologic gastric and/or small intestinal eosinophilia lacking an approved therapy. An allergic mechanism is postulated but underexplored mechanistically and therapeutically. We evaluated the effectiveness of a food allergen–free diet (elemental formula) in controlling gastrointestinal eosinophilia in adult EoG/EoGE. Adults aged 18 to 65 years with histologically active EoG/EoGE (≥30 eosinophils per high-power field) in the stomach and/or duodenum and gastrointestinal symptoms within the month preceding enrollment were prospectively enrolled onto a single-arm clinical trial to receive elemental formula for 6 consecutive weeks. The primary end point was percentage of participants with complete histologic remission (<30 eosinophils per high-power field in both stomach and duodenum). Exploratory outcomes were improvement in symptoms, endoscopy results, blood eosinophilia, quality of life, Physician Global Assessment score, and EoG-relevant gastric transcriptome and microbiome. Fifteen adults (47% male, average age 37.7 years, average symptom duration 8.8 years) completed the trial. Multi–gastrointestinal segment involvement affected 87%. All subjects had complete histologic remission in the stomach (P = .002) and duodenum (P = .001). Scores improved in overall PhGA (P = .002); EGREFS (P = .003); EGDP (P = .002); SODA pain intensity (P = .044), non-pain (P = .039), and satisfaction (P = .0024); and PROMIS depression (P = .0078) and fatigue (P = .04). Food reintroduction reversed these improvements. The intervention was well tolerated in 14 subjects, with 1 serious adverse event reported in 1 subject. An amino acid–based elemental diet improves histologic, endoscopic, symptomatic, quality-of-life, and molecular parameters of EoG/EoGE; these findings and disease recurrence with food trigger reintroduction support a dominant role for food allergens in disease pathogenesis. ClinicalTrials.gov Identifier: NCT03320369.