A one-food elimination diet (1FED) could be just as effective as the popular six-food elimination diet (6FED) for patients suffering from eosinophilic esophagitis (EoE), a randomized trial showed.
Removing animal milk alone led to histological remission at 6 weeks in 35% of people by eosinophil count, which was statistically no different than the 42% in people who eliminated the six most common food allergens from their diet, reported Marc Rothenberg, MD, PhD, allergic inflammatory disease specialist of Cincinnati Children's Hospital Medical Center, and colleagues.
The similarity between groups persisted even if partial remission was defined under a more strict eosinophil count, according to the study published in and presented by Rothenberg at this year's .
"Our findings indicate that eliminating animal milk alone is an acceptable initial dietary therapy for eosinophilic esophagitis," study authors concluded.
"The disease is mediated by hypersensitive adaptive immunity driven by T cells that recognize milk proteins and then liberate certain type 2 cytokines that then induce allergic inflammatory responses in the esophagus," Rothenberg explained to ѻý Today.
His group's results provide both clarity and reinforcement surrounding research on dietary items that affect eosinophilic esophagitis, as well as possible methods to lessen its symptoms. Eosinophilic esophagitis is a chronic, progressive disease in which eosinophils accumulate in the epithelial lining of the esophagus, leading to inflammation and injury that can harshly limit the individual's ability to swallow easily.
Last year, the monoclonal antibody treatment dupilumab (Dupixent) became the first drug approved to treat eosinophilic esophagitis in adults and pediatric patients ages 12 and older.
"Although effective pharmacological treatments are available, the most intuitive therapy is to identify and eliminate specific food exposures, thereby preventing initiation of the inflammatory cascade. However, no reliable tests are readily available to identify the triggering foods. As a result, empirical elimination of the six most common food allergens [milk, wheat, soy, eggs, nuts, and seafood] is often used to achieve histological remission," Rothenberg's group wrote.
The problem with the 6FED protocol is that many patients don't find it acceptable, as it includes common foods that are not easy to eliminate, and multiple endoscopies are required to monitor response.
Surgeon Stephen Attwood, MD, of Durham University, England, commented that a less restrictive diet has the potential to be a much more practical and enjoyable option for patients suffering from eosinophilic esophagitis.
"Given the complexity of life when trying to avoid six foods and the great difficulty in sustaining such an effort for more than a year, this evidence on the value of keeping dietary therapy simple is important," Attwood wrote in an .
"As well as being easier to comply with, a single-food elimination diet (or perhaps a two-food elimination diet avoiding milk and wheat) requires fewer repeat endoscopies than the seven endoscopies needed to determine which foods are relevant in the multifood approach," he added.
Several secondary endpoints of the trial supported 1FED as a match for standard 6FED:
- Peak eosinophil counts decreased to a similar extent between groups
- Drops from baseline in Eosinophilic Esophagitis Histology Scoring System, Eosinophilic Esophagitis Endoscopic Reference Score, and Eosinophilic Esophagitis Activity Index were comparable
- Similar changes in quality of life scores were observed on the Adult Eosinophilic Esophagitis Quality-of-Life and Patient Reported Outcome Measurement Information System Global Health questionnaires
However, rates of complete remission significantly favored 6FED (19% vs 6%, P=0.031).
Among patients without histological response to 1FED who proceeded to 6FED, 43% reached histological remission; among those without histological response to 6FED who proceeded to steroid therapy, 82% reached histological remission.
For the study, adults aged 18 to 60 experiencing eosinophilic esophagitis were randomly assigned to participate in either the 6FED of 1FED diet over 12 weeks.
Halfway through the elimination period, patients were given an upper endoscopy with a biopsy to track progress. At that point, if the patient did not have a histological response, they were allowed to stop their participation in the trial or change the restriction method used.
Patients in the 6FED group not responding to treatment were given 880 μg fluticasone propionate twice daily and were allowed to have an unrestricted diet for up to 4 weeks between the two treatment phases. At 12 weeks, a second endoscopy was performed.
Adverse events remained below 5% for both 1FED or 6FED groups.
Limitations of the trial include patients using proton pump inhibitor being excluded, treatments not being masked, and the uncertainty around the strictness with which participants adhered to the diet limitations, the investigators acknowledged.
Disclosures
This study was funded by the U.S. National Institutes of Health.
Rothenberg is a consultant for AstraZeneca, Bristol Myers Squibb, Regeneron-Sanofi, Revolo Biotherapeutics, Celldex, Nexstone One, and Guidepoint; has received research support from AstraZeneca, Regeneron-Sanofi, GlaxoSmithKline, the CURED Foundation, Food Allergy Fund, and a US–Israel Binational Grant; has equity interest in PulmOne Therapeutics, Spoon Guru, ClostraBio, Serpin Pharm, Celldex, Nexstone One, and Allakos; receives royalties from Ception Therapeutics, Mapi Research Trust, and UpToDate; has received equipment from Phadia; has a leadership role in the International Eosinophil Society; has received payment for expert testimony from Tucker Ellis; and is an inventor on a patent owned by Cincinnati Children's Hospital Medical Center. Study co-authors reported various relationships with industry, government, and other non-governmental organizations.
Attwood reported relationships with Regeneron/Sanofi, Dr Falk Pharma, GSK, Bristol Myers Squibb, and AstraZeneca.
Primary Source
The Lancet Gastroenterology & Hepatology
Kliewer KL, et al "One-food versus six-food elimination diet therapy for the treatment of eosinophilic esophagitis: a multicentre, randomized, open-label trial" Lancet Gastroenterol Hepatol 2023; DOI: 10.1016/S2468-1253(23)00012-2.
Secondary Source
The Lancet Gastroenterology & Hepatology
Attwood SE "Bringing dietary therapy for eosinophilic esophagitis under scientific scrutiny" Lancet Gastroenterol Hepatol 2023; DOI: 10.1016/S2468-1253(23)00041-9.