Monday, February 27, 2023
NIH recipients report results of the first multisite randomized trial comparing the two regimens.
Eliminating animal milk alone from the diet of adults with eosinophilic esophagitis, or EoE, is as effective at treating the disease as eliminating animal milk and five other common foods, according to a clinical trial funded by the National Institutes of Health. For people with EoE whose disease remains active after giving up animal milk, a more restrictive diet may help them achieve remission, researchers say. These results were published today in the journal The Lancet Gastroenterology & Hepatology.
“Dietary therapy for eosinophilic esophagitis will be much easier for many people to follow if it involves removing just one food from the diet rather than six,” said Hugh Auchincloss, MD, acting director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.
EoE is a chronic disease characterized by an overabundance of white blood cells called eosinophils in the esophagus. Allergic inflammation from food leads to disease by damaging the esophagus and preventing it from working properly. For people with EoE, swallowing even small amounts of food can be a painful and stressful choking experience. About 160,000 people in the United States live with EoE.
The exclusion of certain foods from the diet has been a cornerstone of EoE treatment. In the early 2000s, researchers found that eliminating six common dietary triggers of esophageal damage – milk, eggs, wheat, soy, fish and nuts – significantly reduced the signs and symptoms of esophageal inflammation. ‘EoE. This six-food elimination diet (6FED) has become a common approach to managing the disease.
In recent years, scientists have conducted small, non-randomized studies of removing one to four of the most common food antigens from the diet to treat EoE, with some success. However, the relative risks and benefits of eliminating many versus few foods at the start of diet therapy remained unclear.
The new results come from the first multisite randomized trial comparing 6FED to a one-food elimination diet (1FED) in adults with EoE. The trial was co-funded by NIAID, the National Center for Advancing Translational Sciences, and the National Institute of Diabetes and Digestive and Kidney Diseases, all part of the NIH. Marc E. Rothenberg, MD, Ph.D., the lead author of the published study, is director of both the Division of Allergy and Immunology and the Cincinnati Center for Eosinophilic Disorders at the Cincinnati Children’s.
The trial involved 129 adults aged 18 to 60 with a confirmed EoE diagnosis, active EoE symptoms, and high eosinophil counts in esophageal tissue. The volunteers enrolled in the trial at one of 10 US medical centers that participate in the Consortium of Eosinophilic Gastrointestinal Disease Researchers, part of the NIH-funded Rare Diseases Clinical Research Network. Participants were randomly assigned to either 1FED, which eliminated only animal milk from the diet, or 6FED. They followed their diet for six weeks, then underwent an upper endoscopic examination and biopsy of esophageal tissue. If the number of eosinophils in the tissue indicated that the EoE was in remission, the participant left the study. If the EoE was not in remission, people who had been on 1FED could be switched to 6FED, and people who had been on 6FED could be taken topical steroids swallowed, both for six weeks, followed by retest with tissue biopsy.
Investigators found that 34% of 6FED participants and 40% of 1FED participants achieved remission after six weeks of diet therapy, a difference that was not statistically significant. Both diets also had a similar impact on several other measures, including reduction in EoE symptoms and effect on quality of life. Thus, 1FED and 6FED were equally effective in treating EoE, an unexpected finding.
The researchers also found that nearly half of those who did not respond to 1FED achieved remission after treatment with the more restrictive 6FED, while more than 80% of 6FED non-responders achieved remission with oral steroids.
Taken together, the researchers conclude that 1FED is a reasonable first-line dietary therapy option for adults with EoE, and that effective therapies are available for people who do not achieve remission after 1FED or 6FED.
NIAID conducts and supports research—at the NIH, in the United States, and around the world—to study the causes of infectious and immune-mediated diseases and to develop better ways to prevent, diagnose, and treat these diseases. Press releases, fact sheets, and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH):The NIH, the country’s medical research agency, comprises 27 institutes and centers and is part of the US Department of Health and Human Services. The NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about the NIH and its programs, visit www.nih.gov.
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KL Kliewer et al. One-food versus six-food elimination diet therapy for the treatment of eosinophilic esophagitis: a multicenter, randomized, open-label trial. The Lancet Gastroenterology & Hepatology DOI: 10.1016/S2468-1253(23)00012-2 (2023).