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Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.
There were no serious adverse events or treatment-related adverse events identified in either treatment group.
The Crohn’s disease exclusion diet (CDED) can be an effective option for adults with mild-to-moderate Crohn’s disease, with or without partial enteral nutrition.
A team, led by Henit Yanai, MD, Division of Gastroenterology, Rabin Medical Center, assessed CDED in adult patients with Crohn’s disease.
For pediatric patients with mild-to-moderate Crohn’s disease, CDED with partial enteral nutrition effectively induces remission.
In the open-label, pilot randomized trial at 3 medical centers in Israel, the investigators examined biologic naïve adults between 18-55 years with mild-to-moderate Crohn’s disease, defined by a Harvey-Bradshaw Index score of 5-14 points. The patients also had a maximal disease duration of 5 years, active disease on colonoscopy, or imaging with elevated inflammatory markers (C-reactive protein >5 mg/L or fecal calprotectin concentration >200 μ/g).
Overall, 91 patients were screened between January 12, 2017 and May 11, 2020. Of this group, 44 participants were assigned to the CDED with partial enteral nutrition group (n = 20) or CDED alone (n = 24). In addition, 19 participants in the CDED with partial enteral nutrition group and 21 individuals in the CDED alone arm received the allocated intervention for at least 48 hours and were included in the intention-to-treat analysis.
Each patient was randomly assigned to either the CDED with partial enteral nutrition group or CDED alone for 24 weeks.
The investigators sought primary endpoints of clinical remission, which was defined as a Harvey-Bradshaw Index score of less than 5 at week 6. This was assessed in the intention-to-treat population, which included all patients who used the dietary therapy for at least 48 hours.
At the 6 week mark, 68% (n = 13) of patients in the CDED plus partial enteral nutrition group and 57% (n = 12) patients in the CDED group achieved clinical remission (P = 0.4618).
For the 25 patients in remission at week 6, 80% (n = 20) were in sustained remission at week 24, 12 patients in the CDED with partial enteral nutrition group and 8 patients in the CDED alone cohort.
In addition, 35% (n = 14) of patients were in endoscopic remission at week 24, 8 patients in the CDED plus partial enteral nutrition group and 6 individuals in the CDED alone group.
For safety, there were no serious adverse events or treatment-related adverse events identified in either treatment group.
“CDED with or without partial enteral nutrition was effective for induction and maintenance of remission in adults with mild-to-moderate biologic naive Crohn's disease and might lead to endoscopic remission,” the authors wrote. “These data suggest that CDED could be used for mild-to-moderate active Crohn's disease and should be assessed in a powered randomized controlled trial.”
The study, “The Crohn's disease exclusion diet for induction and maintenance of remission in adults with mild-to-moderate Crohn's disease (CDED-AD): an open-label, pilot, randomized trial,” was published online in The Lancet Gastroenterology & Hepatology.