The National Institutes of Health (NIH) has funded a clinical trial that has found that eliminating animal milk alone from the diet of adults with eosinophilic esophagitis (EoE) is just as effective at treating the disease as eliminating animal milk plus five other common foods. The trial is the first multi-site, randomized trial comparing the six-food elimination diet (6FED) with a one-food elimination diet (1FED) in adults with EoE. EoE is a chronic disease characterized by an overabundance of white blood cells called eosinophils in the esophagus, and allergic inflammation due to food drives the 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. Excluding certain foods from the diet has been a cornerstone of EoE treatment, and the 6FED has been a common approach to managing the disease.
The trial involved 129 adults ages 18 to 60 years with a confirmed EoE diagnosis, active EoE symptoms, and a high number of eosinophils in esophageal tissue. Participants were assigned at random to either the 1FED, which eliminated only animal milk from the diet, or the 6FED. They followed their assigned diet for six weeks, then underwent an upper endoscopy exam and an esophageal tissue biopsy. If the number of eosinophils in the tissue indicated that EoE was in remission, the participant exited the study. If EoE was not in remission, people who had been on 1FED could advance to 6FED, and people who had been on 6FED could take topical swallowed steroids, both for six weeks, followed by a repeat exam with tissue biopsy.
The investigators found that 34% of participants on 6FED and 40% of participants on 1FED achieved remission after six weeks of diet therapy, a difference that was not statistically significant. The two diets also had a similar impact across several other measures, including reduction in EoE symptoms and effect on quality of life. Thus, 1FED and 6FED were equally effective at treating EoE, an unexpected finding.
For people with EoE whose disease remains active after they forgo animal milk, a more restrictive diet may help them achieve remission, according to the researchers. The researchers also discovered that nearly half of people who did not respond to 1FED attained remission after treatment with the more restrictive 6FED, while more than 80% of the non-responders to 6FED achieved remission with oral steroids. Taken together, the investigators conclude that 1FED is a reasonable first-line diet therapy option in adults with EoE, and that effective therapies are available for people who do not achieve remission after 1FED or 6FED.
The findings were published today in the journal The Lancet Gastroenterology & Hepatology. Hugh Auchincloss, M.D., acting director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, said, “Diet-based therapy for eosinophilic esophagitis will be much easier to follow for many people if it involves cutting just one food from the diet rather than six.”»NIH funds new clinical trial«