Effect of the Crohn’s Disease Exclusion Diet (CDED) on the Fecal Calprotectin Level in Children with Active Crohn’s Disease

Abstract

(1) Background: The CDED + PEN (partial enteral nutrition) is a promising method of nutritional treatment in active Crohn’s disease (CD). An increase in fecal calprotectin (FCP) level—a marker of mucosal inflammation—happens to be the first evidence of Crohn’s disease exacerbation that appears ahead of clinical symptoms and usually co-exists with them. In this study, we present our own experience with using the CDED + PEN in the treatment of children with CD and an increased FCP level. (2) Methods: In total, 48 children (male/female: 27/21) aged 4–17 years (median value = 13.43; IQR = 4.00) were treated with CDED + PEN between June 2019 and July 2021. The main inclusion criteria for the study was active CD defined as an FCP level ≥ 250.00 µg/g. Patients with severe clinical manifestation of CD (PCDAI >40.00), as well as ones who started any new concomitant CD treatment later than at least 4 weeks before the start of dietary intervention, were excluded from the analysis. The PCDAI and fecal calprotectin level were assessed at weeks 0 and 12. The primary endpoint was ITT normalization of FCP level, i.e., a result < 250.00 µg/g at week 12. The Wilcoxon Matched Pairs Test was used for statistical analysis. (3) Results: The normalization of the FCP level was obtained in 17 children (35.42%) and an FCP level decrease of at least 50% occurred in 26 patients (54.17%). The reduction in fecal calprotectin level between week 0 and week 12 was statistically significant with a median value of 1045.00 µg/g; IQR = 1188.00, and 363.00 µg/g; IQR = 665.00, respectively (p < 0.05). Among 29 patients who were not in clinical remission at baseline, 16 (55.17%) achieved clinical remission (PCDAI < 10.00) at week 12 and 20 (68.97%) obtained a clinical response defined as at least a 12.50 point drop in PCDAI or remission. In this group, the reduction in PCDAI between baseline and week 12 was statistically significant (median value = 20.00 points; IQR = 7.50 and 5.00 points; IQR = 5.00, respectively (p < 0.05)). All patients with a normal FCP level at week 12 were in clinical remission and 16 (94.13%) of them had a normal CRP (C-reactive protein) value. In 10 children (20.83%) the full course of 12 weeks with CDED + PEN was not completed or the concomitant therapy had been started before week 12 due to the lack of efficacy/intolerance of nutritional treatment. (4) Conclusions: The 12-week course of treatment with the CDED + PEN has a beneficial effect on the fecal calprotectin level in children with active CD. The dietary intervention led to a significant decrease in the FCP level in the studied group and to the normalization of this parameter in every third patient.

Effects of Crohn’s disease exclusion diet on remission: a systematic review

“…Five of these studies were conducted in Israel 10 , 12 , 14 , 18 , 19 , one in Israel and Canada, 10 and two in Poland. 20 , 21 With regard to the study design, two of these studies were RCTs 10 , 12 whereas five were prospective nonrandomized studies. 14 , 18 – 21 Two studies targeted children, 10 , 21 , three targeted adults.…”

“… 20 , 21 With regard to the study design, two of these studies were RCTs 10 , 12 whereas five were prospective nonrandomized studies. 14 , 18 – 21 Two studies targeted children, 10 , 21 , three targeted adults. 12 , 18 , 20 Sigall et al 14 , 19 included both adults and children.…”

“…Three studies reported the remission of pediatric CD patients, 10,14,21 following the gradual introduction of free oral diet at 12 weeks (phase II). Levine et al 10 14 also noted that at week 12, PCDAI declined significantly compared with week 0 (p = 0.000) and Matuszczyk et al 21 found that 29 out of 48 CDED+PEN patients were in clinical remission at week 12, which was statistically significant compared with week 0 (p = 0.002). Table 3 summarizes the remission rates in children with CD treated with CDED.…”

An update on dietary therapies in paediatric Crohn's disease

“…Likewise, in an uncontrolled open-label study of 48 children with mild-to-moderate CD and increased FCAL, 12-weeks of CDEDþPEN decreased levels of FCAL. Normalisation of FCAL (FCAL< 250 mg/kg) was achieved in 35% of patients and a 50% reduction from baseline in 54% of patients [32]. A modified version of CDED, adapted to Slovenian cuisine, and coupled with 75% PEN produced comparable clinical, endoscopic remission and mucosal healing rates to EEN [33].…”

Take-Home Messages from 20 Years of Progress in Dietary Therapy of Inflammatory Bowel Disease

“…In addition to these dietary exclusions, CDED is coupled with 50% PEN and the daily mandatory intake of 5 foods (i.e., chicken, eggs, potato, apple, and banana). Reproducible data shows that CDED + PEN improves disease activity and faecal/systemic inflammatory biomarkers [46, 47]. However, the specific mode of action remains elusive, and the choice of dietary restrictions is arbitrary rather than strictly scientifically justified.…”