Effectiveness of Crohn’s Disease Exclusion Diet for Induction of Remission in Crohn’s Disease Adult Patients

Abstract

INTRODUCTION The Crohn’s disease exclusion diet (CDED) has a well-documented effectiveness in inducing remission in active Crohn’s disease (CD) in children. However, the data for adult population are limited. The aim of the study was to evaluate the effectiveness of the CDED with a supply of liquid formula Modulen (Nestlé) in inducing remission in CD adult patients. MATERIALS AND METHODS Between March 2020 and May 2021, an open label, non-randomized, single centre study was conducted in gastroenterology outpatient center. 32 patients with active CD (Crohn’s disease activity index CDAI >150 points) were treated with CDED with a supply of Modulen (Nestlé). The patients were seen at baseline, at week 6 and at week 12 of the study. During the visits anthropometric measurements, laboratory test, CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ) were performed. Data analysis was based on an intention-to-treat approach. Statistical analysis was carried out using R software, version 4.0.5. Normality of the distribution was validated using the Shapiro–Wilk test, skewness and kurtosis values and on visual assessment of histograms. Comparison between three measurements was conducted with ANOVA for repeated measures or a series of Wilcoxon signed-rank tests. The primary endpoint was the achievement of remission at week 12 (CDAI<150 points). The secondary endpoints were the inducement of a clinical response (a reduction in CDAI by 100 points or more), improved quality of life and an improvement in laboratory parameters and BMI. RESULTS 32 participants were included in the study. The baseline CDAI was 253 points (175.50; 373.00) (from 151 to 562 points). Baseline calprotectin was at a median level of 393 μg/g (58.85; 969.00), ranging from 11.9 to 4 630 μg/g. A statistically significant drop in CDAI was observed after 6 weeks (p <0.001) and after 12 weeks (p <0.001) of dietary intervention as compared to baseline (Figure 1). IBDQ was significantly higher (p <0.001) at the first and second follow-up vs baseline. Calprotecin levels were significantly lower at the second follow-up vs baseline (p =0.021) (Figure 2). A clinical response was observed in 83.3% of the patients (CI95 [65.3%–94.4%]) after 6 weeks of treatment and in 85.7% of cases (CI95 [67.3%–96.0%]) after 12 weeks of treatment. A clinical remission was present after 6 weeks of treatment vs baseline in 76.7% of patients (CI95[57.7%–90.1]) and in 82.1% of participants (CI95[63.1%–93.9]) after 12 weeks of treatment vs baseline. CONCLUSIONS The CDED with a supply of liquid formula is an effective therapy for inducing remission in the adult CD population. However, a randomised trial is needed to obtain higher-level evidence.