NNumerous clinical studies and meta-analysis have confirmed that exclusive enteral nutrition (EEN) is as effective as corticosteroids (CS) for induction of remission in active pediatric Crohn’s disease (CD). Moreover, EEN was shown to be more effective than CS in achieving mucosal healing (MH), therefore consensus guidelines of the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommend EEN as a first-line therapy in children with active CD. Despite the numerous benefits of EEN, this treatment strategy is still underused in clinical practice. The most important barrier, preventing widespread use of EEN, is patient compliance. Adhering to the EEN regimen is difficult for most patients as they are only allowed to consume liquid enteral formula during the 6–8-week treatment period. Recently, partial enteral nutrition (PEN) has come into the forefront of pediatric CD treatment research, as it allows patients to consume some solid food alongside the enteral formula, improving the quality of life and patient compliance. So far, all previous studies on PEN have only evaluated the clinical response to PEN treatment, furthermore, no study has evaluated the effect of PEN on mucosal healing in CD. Therefore, the primary goal of our study was to evaluate not only the clinical outcomes of PEN, but the endoscopic remission and mucosal healing rates after a 6-week treatment course with PEN, as well as to compare the outcomes of PEN treatment to the standard EEN treatment protocol.
At our Department of Pediatric Gastroenterology, Hepatology and Nutrition, from June 2017 until the end of February 2021, 54 children and adolescents with clinically and endoscopically confirmed active CD were screened for inclusion into our study. Fifteen patients were excluded based on the exclusion criteria. Additionally, three patients were excluded as they chose CS over nutritional treatment and another 3 patients due to being treated with a different enteral nutrition formula which wasn’t part of the treatment protocol. Finally, 33 patients were included into our study on intention to treat (ITT) analysis. Nineteen patients were included into the EEN and 14 into the PEN group. Thirteen patients in the PEN group and 16 patients in the EEN group concluded 6 weeks of nutritional treatment and were therefore included into per protocol (PP) analysis. All patients in the EEN group were treated with the same polymeric enteral formula (Alicalm, Nutricia, Nehterlands) in accordance with the standard treatment protocol, where 100% of daily energy requirements are covered with an enteral formula. In the PEN group, 75% of daily energy requirements were supplied by an enteral formula, while children were allowed one meal per day from an anti-inflammatory diet (AID). The AID was based on the CD Exclusion Diet (CDED), which was modified to fit the Slovenian dietary habits. CDED is grounded on recent scientific findings and excludes dietary components that negatively affect either intestinal permeability or the microbiome. Our AID differs from CDED in that it allows patients to consume locally sourced fruit and vegetables. CDED permits the consumption of rice and potatoes, our AID additionally allows buckwheat and millet, but excludes fried foods and promotes the use of healthy vegetables oils, especially olive oil.
On ITT analysis, clinical remission (Pediatric CD Activity Index < 10) was achieved in 78.5% of patients in the PEN and 68.4% of patients in the EEN group (p=0.698), respectively. On per protocol analysis 84.6% of patients in the PEN and 81.3% of patients in the EEN group achieved clinical disease remission (p = 0.999). Endoscopic remission, defined as Simple Endoscopic Score for CD (SES-CD) ⡤ 2, was observed in 53.8% of patients in the PEN and in 50.0% of patients in the EEN group (p = 0.999) and mucosal healing (SES-CD = 0) was found in 38.5% of patients in the PEN and in 43.8% of patients in the EEN group (p = 0.999). Mean PCDAI and SES-CD index values significantly decreased in both groups and no difference between groups was observed (p = 0.881 for PCDAI; p = 0.750 for SES-CD). Furthermore, a statistically significant decrease in mean erythrocyte sedimentation rate, C-reactive protein, mean thrombocyte count and fecal calprotectin was found in both groups with no significant differences between the two groups in the change of the abovementioned parameters during a 6-week treatment course. During the treatment period, no statistically significant increases in the patients’ mean blood hemoglobin levels or anthropometric parameters were observed for either group.
In our study, our novel PEN treatment protocol, allowing one meal per day from an anti-inflammatory diet, was comparable in effectiveness to standard EEN treatment in inducing clinical and endoscopic remission in pediatric patients with active CD. Our PEN protocol allows patients to consume one meal per day alongside the enteral nutrition formula, which positively impacts the patients’ quality of life.
Our research project contributes to scientific research with the development of a novel nutritional treatment protocol, which combines 75% of daily required energy intake from an enteral formula with one allowed meal per day from an anti-inflammatory diet.
Furthermore, our study is the first to assess not only clinical but also endoscopic remission and mucosal healing rates in the treatment of CD with partial enteral nutrition.
|
