NEW YORK (Reuters Health) – The Crohn’s disease (CD) exclusion diet (CDED), with or without partial enteral nutrition, appeared to induce and maintain remission in patients with mild-to-moderate biologic-naive disease in a pilot trial from Israel.
Dietary therapy using the CDED is associated with a reduction in inflammation and induction of mucosal healing in patients with mild-to-moderate CD, which may consequently support achievement of therapeutic goals without the need of immune suppression, according to Dr. Henit Yanai of the Rabin Medical Center, in Petah Tikva, and colleagues.
The CDED emphasizes food sources of water-soluble fiber and resistant starch, predominantly from vegetables and fruits, the researchers note in The Lancet Gastroenterology and Hepatology. During each phase of the diet, patients are allowed access to a broader range of certain foods. Despite data supporting the diet with partial enteral nutrition in children, there are currently no prospective data on CDED in adults, the team says.
To investigate, Dr. Yanai and colleagues randomly assigned 44 adult CD patients at three medical centers to receive either CDED plus partial enteral nutrition or CDED alone for a total of 24 weeks. Patients had not been treated with biologics, were between the ages of 18 and 55 years and had mild-to-moderate disease. The study was not blinded.
The median disease duration was three months in each treatment group. At baseline, the median concentrations of C-reactive protein (CRP) were 16.8 mg/L in patients on CDED and partial enteral nutrition and 12.1 mg/L in those on CDED alone.
At the six-week follow-up period, 68% of patients in the former group and 57% of patients in the latter group (P=0.5) had achieved clinical remission, defined as a Harvey-Bradshaw Index score of less than 5.
Among patients who were in remission, 20 (80%) continued to be so through week 24. A higher number of patients in sustained remission at 24 weeks was reported in the CDED plus partial enteral nutrition group, but this difference was not statistically significant (12 vs. eight; P=0.1).
The overall 24-week rate of endoscopic remission was 35%, including eight patients on CDED plus partial enteral nutrition and six patients on CDED alone (P=0.7).
A significant decrease was observed in CRP among the 30 patients with elevated CRP at baseline. There were no serious adverse events or treatment-related adverse events in either group.
The researchers say that while this was a pilot trial, the findings suggest that the CDED “could be used in adults with uncomplicated mild-to-moderate Crohn’s disease at diagnosis and possibly serve as a therapeutic alternative for patients who cannot receive medical therapy due to underlying health conditions.”
Dr. Alexa Sasson of Harvard Medical School, in Boston, who wrote a linked comment in the journal, told Reuters Health by email that the new findings support greater incorporation of the CDED into CD care. But she urges clinicians to use a diet that also takes into consideration a patient’s interest, goals, and state of disease.
“The CDED is not part of routine care,” she said, “though this pilot study provides support towards growing literature for dietary therapy for Crohn’s disease in subset of individuals.”
The study was supported by Nestle Health Science. Three of the authors report ties to the company.
Dr. Yanai did not respond to a request for comment.
SOURCE: https://bit.ly/3cJgTLf and https://bit.ly/2ZeJHIg The Lancet Gastroenterology and Hepatology, online November 2, 2021.
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