Results of the first multi-site randomized trial comparing the two diets – ScienceDaily

A clinical trial funded by the National Institutes of Health has found that eliminating animal milk alone from the diet of adults with eosinophilic esophagitis, or EoE, can help treat the disease. plus five other common foods. For people with EoE whose disease remains active after avoiding animal milk, a more restrictive diet may help them achieve remission, according to the researchers. These results were published in the journal today The Lancet Gastroenterology & Hepatology.

“Dietary therapy for eosinophilic esophagitis will be much easier to follow for many people if it involves cutting one food from the diet instead of six,” said Hugh Auchincloss, MD, acting director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH.

EoE is a chronic disease characterized by the over-proliferation of white blood cells called eosinophils in the esophagus. Allergic inflammation caused by 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 experience. About 160,000 people in the United States live with EoE.

A cornerstone of EoE treatment has been the exclusion of certain foods from the diet. During the early 2000s, researchers found that eliminating six common food causes of esophageal injury — milk, eggs, wheat, soy, fish and nuts — significantly reduced the signs and symptoms of 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 good success. However, the relative risks and benefits of eliminating many foods versus a few foods at the start of diet-based therapy remain unclear.

The new results come from the first multi-site, randomized trial comparing the 6FED with a single-food elimination diet (1FED) in adults with EoE. The trial was jointly funded by NIAID, the National Center for the Advancement of Translational Sciences, and the National Institute of Diabetes and Digestive and Kidney Diseases, part of NIH. Marc E. Rothenberg, MD, Ph.D., senior author of the published study, is director of the Division of Allergy and Immunology and the Cincinnati Center for Eosinophilic Disorders at Cincinnati Children’s.

The trial included 129 adults aged 18 to 60 years with a confirmed EoE diagnosis, active EoE symptoms, and high eosinophils in esophageal tissue. Volunteers enrolled in the trial at one of 10 US medical centers participating in the Eosinophilic Gastrointestinal Disease Research Consortium, part of the NIH-funded Rare Disease Clinical Research Network. Participants were randomly assigned to 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 and esophageal tissue biopsy. If the number of eosinophils in the tissue indicated that EoE was in remission, the participant left the study. If EoE was not in remission, people on 1FED could progress to 6FED, and people on 6FED could take oral topical steroids, for six weeks, followed by re-examination 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. Both diets had similar effects across several other measures, including a reduction in EoE symptoms and an effect on quality of life. Thus, 1FED and 6FED were equally effective in treating EoE, an unexpected result.

The researchers also found that nearly half of the 1FED non-responders achieved remission after treatment with the more restrictive 6FED, and more than 80% of the 6FED non-responders achieved remission with oral steroids.

Collectively, the investigators 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.

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