Oral exclusive enteral nutrition for induction of clinical remission, mucosal healing, and improvement of nutritional status and growth velocity in children with active Crohn's disease - a prospective multicentre trial

Introduction: Undernutrition and growth failure are common problems in paediatric patients with active Crohn's disease (CD). Aim: The aim of exclusive enteral nutrition (EEN) commencement is not only to induce clinical remission and promote mucosal healing but also to initiate weight and growth gain, especially in patients with poor nutritional status. We assessed the effectiveness of treatment with EEN and its impact on nutritional status in children with active CD. Material and methods: Twenty children (male/female: 14/6) in median age of 14 years with active CD had EEN with polymeric industrial diet (Modulen IBD) applied for 6 weeks. The daily caloric intake was established according to the age and nutritional status. In patients with undernutrition, it was increased to 120-150% relative to recommendations for the healthy peers. The Paediatric CD activity index (PCDAI) - a marker of clinical remission, faecal calprotectin (FCP) - a marker of mucosal healing (MH), and nutritional status were assessed at baseline and 4 weeks following the end of the therapy (week 10). Results: In the studied group the mean decrease in PCDAI score was statistically significant (from 25.6 +/- 12 to 5.4 +/- 10, p < 0.05). Full remission (defined as PCDAI < 10) was achieved in 65% of patients, and clinical response in another 30% of them. Only 5% of children did not respond to the treatment. Mean decline in FCP level was statistically significant as well (from 3380 +/- 7746 to 1046.6 +/- 1219, p < 0.05). All patients, apart from one who was fed with a nasogastric tube, accepted oral intake of industrial formula. EEN was generally well tolerated. Initially, in 20% of patients the symptoms of intolerance to the industrial diet were observed, but they receded within the first days of the therapy. The recommended daily intake of the formula was achieved in 95% of children. Only one child was unable to intake the prescribed amount of the diet due to intolerance. At baseline, undernutrition was observed in 30% of patients, which was established by a body mass index (BMI) score below the third percentile according to the recommended charts for the Polish paediatric population. In all patients, improvement in BMI status was reported at the end of the treatment. The mean increase in BMI score was 0.91, and it was greater in the malnourished group compared to patients with normal nutritional status (1.19 vs. 0.62). After the treatment two-thirds of children with malnutrition achieved a BMI score within the normal range. In 25% of patients, growth deficit was observed (defined as growth below the third percentile according to the Polish charts) before the EEN introduction. An increase in body height was obtained generally in 55% of children and in 80% of those with initial growth failure. The mean increase in growth was 1 cm, and it was greater in the group with initial growth deficit relative to patients with baseline normal height (1.5 cm vs. 0.8 cm, respectively). Conclusions: A 6-week course of oral EEN was an effective and well-tolerated method of treatment in children with active CD. Nutritional therapy not only induced full clinical remission and led to decline in FCP level (as a marker of MH) in the majority of patients, but also contributed to the improvement in their nutritional status and growth velocity. These are very important observations because proper development is crucial for paediatric CD patients.