Prospective study of an amino acid-based elemental diet in an eosinophilic gastritis and gastroenteritis nutrition trial.
Eosinophilic gastritis
elemental diet
eosinophilia
eosinophilic gastroenteritis
food allergy
Journal
The Journal of allergy and clinical immunology
ISSN: 1097-6825
Titre abrégé: J Allergy Clin Immunol
Pays: United States
ID NLM: 1275002
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
received:
06
01
2023
revised:
21
04
2023
accepted:
11
05
2023
pmc-release:
01
09
2024
medline:
11
9
2023
pubmed:
18
7
2023
entrez:
18
7
2023
Statut:
ppublish
Résumé
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. gov Identifier: NCT03320369.
Sections du résumé
BACKGROUND
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.
OBJECTIVE
We evaluated the effectiveness of a food allergen-free diet (elemental formula) in controlling gastrointestinal eosinophilia in adult EoG/EoGE.
METHODS
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.
RESULTS
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.
CONCLUSION
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.
Identifiants
pubmed: 37462600
pii: S0091-6749(23)00753-4
doi: 10.1016/j.jaci.2023.05.024
pmc: PMC10528593
mid: NIHMS1919536
pii:
doi:
Substances chimiques
Amino Acids
0
Allergens
0
Banques de données
ClinicalTrials.gov
['NCT03320369']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Research Support, N.I.H., Extramural
Research Support, N.I.H., Intramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
676-688Subventions
Organisme : NIAID NIH HHS
ID : U54 AI117804
Pays : United States
Informations de copyright
Copyright © 2023 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
Références
Clin Gastroenterol Hepatol. 2010 Aug;8(8):669-75; quiz e88
pubmed: 20451664
J Allergy Clin Immunol. 2014 Nov;134(5):1114-24
pubmed: 25234644
Int J Mol Sci. 2021 Feb 19;22(4):
pubmed: 33669849
Gut. 1990 Jan;31(1):54-8
pubmed: 2318432
Clin Gastroenterol Hepatol. 2022 Apr;20(4):766-775.e4
pubmed: 34062314
J Allergy Clin Immunol. 2020 Jan;145(1):28-37
pubmed: 31758958
Dig Dis Sci. 2019 Aug;64(8):2231-2241
pubmed: 30982212
J Immunol. 2014 Aug 1;193(3):999-1005
pubmed: 25049430
Am J Gastroenterol. 2019 Jun;114(6):984-994
pubmed: 31008735
Gastroenterology. 2018 Jan;154(2):333-345
pubmed: 28757265
Genes Immun. 2014 Sep;15(6):361-9
pubmed: 24920534
Gastroenterology. 2012 Jun;142(7):1451-9.e1; quiz e14-5
pubmed: 22391333
J Allergy Clin Immunol. 2020 Jan;145(1):255-269
pubmed: 31738990
Gastroenterology. 1995 Nov;109(5):1503-12
pubmed: 7557132
Clin Gastroenterol Hepatol. 2011 Nov;9(11):950-956.e1
pubmed: 21806952
Clin Gastroenterol Hepatol. 2006 Sep;4(9):1097-102
pubmed: 16860614
Qual Life Res. 2018 Jul;27(7):1885-1891
pubmed: 29569016
Am J Gastroenterol. 2014 Aug;109(8):1277-85
pubmed: 24957155
ISME J. 2012 Mar;6(3):610-8
pubmed: 22134646
Dig Liver Dis. 2015 Mar;47(3):197-201
pubmed: 25547198
J Pediatr Gastroenterol Nutr. 2015 Jul;61(1):56-64
pubmed: 25699593
Am J Gastroenterol. 2019 Mar;114(3):384-413
pubmed: 30840605
Gastroenterol Clin North Am. 2014 Jun;43(2):257-68
pubmed: 24813514
Gastroenterology. 2018 Jan;154(1):154-167
pubmed: 28912020
Lancet Gastroenterol Hepatol. 2018 Jul;3(7):477-488
pubmed: 29730081
Lancet Gastroenterol Hepatol. 2018 Apr;3(4):271-280
pubmed: 29533199
Gastroenterology. 2013 Dec;145(6):1289-99
pubmed: 23978633
Mod Pathol. 2011 Apr;24(4):556-63
pubmed: 21169993
Am J Gastroenterol. 2022 Dec 1;117(12):1963-1970
pubmed: 35971213
J Pediatr Gastroenterol Nutr. 2000;30 Suppl:S28-35
pubmed: 10634296
J Clin Epidemiol. 2001 Aug;54(8):755-65
pubmed: 11470383
N Engl J Med. 2020 Oct 22;383(17):1624-1634
pubmed: 33085861
Psychol Bull. 1992 Jul;112(1):155-9
pubmed: 19565683
J Pediatr Gastroenterol Nutr. 2011 Mar;52(3):300-6
pubmed: 21057327