Il ruolo dello stato nutrizionale nell'influenzare l'attività di malattia in pazienti affetti da Malattie Infiammatorie Croniche Intestinali

Background: Nutritional deficiency, including malnutrition, undernutrition, and overnutrition—are common throughout the disease course. These may result from inadequate intake, altered nutrient requirements and metabolism, malabsorption, excessive gastrointestinal losses, and medication effects. Whether low serum micronutrient levels are a cause or consequence of active disease remains unclear, as does the therapeutic potential of supplementation. Nevertheless, the available evidence consistently shows that active disease is linked to low serum micronutrient concentrations. The objective of this study was to evaluate whether targeted nutritional assessment and correction of identified nutritional deficiencies can modify the risk of disease relapse and activity in patients with IBD. Material and methods: This multicenter, prospective, randomized, open-label study enrolled all patients with a confirmed diagnosis of IBD (either in remission or with mild disease activity) who presented with at least one nutritional deficiency at baseline (T0), including low levels of vitamin D, vitamin B12, folic acid, serum iron, ferritin, albumin, or hemoglobin levels. Eligible patients were randomized in a 1:1:1 ratio to a nutritional supplementation group, a control group, or a healthy control group without any nutritional deficiencies. The efficacy of nutritional interventions, delivered according to a predefined protocol, was assessed at the end of follow-up (T1, 54 weeks). Clinical outcomes included disease activity, evaluated using the Partial Mayo Score and Harvey–Bradshaw Index, as well as therapeutic modifications (e.g., treatment optimization, switching of advanced therapies, or corticosteroid initiation). Quality of life was measured at baseline and at week 54 using the SF-36 and IBD-DI questionnaires. Moreover, the relationship between nutritional status (including micronutrient deficiencies) and clinical as well as laboratoristics disease activity was evaluated at the baseline in patient without any supplementation therapies. Results: At the end of the enrollment period, 120 IBD patients (46 CD; 74 UC) were included. Overall, 27/120 (22%) patients presented clinical activity at the enrollment period. Patients with clinical active disease had significantly lower hemoglobin, iron, ferritin, and vitamin D levels compared to inactive patients (p = 0.007, p < 0.001, p = 0.005, and p = 0.003, respectively). No significant differences were observed for folate, vitamin B12, or albumin. A total of 21/120 patients (17.5%) experienced a clinical relapse during follow-up or had active disease at T1. No significant differences were observed between the intervention and control groups (p = 0.94; 95% CI 0.33–2.79). However, when patients were stratified according to the presence or absence of nutritional deficiencies at baseline, those without deficiencies had a significantly lower risk of clinical relapse (p = 0.047; 95% CI 0.07–0.98). Notably, only patients in the intervention group demonstrated a significant improvement in quality of life, as measured by the SF-36 score, from baseline to the end of follow-up (T0: 118 vs. T1: 142; p = 0.007). Conclusion: The results of this study indicate that, when standard-of-care therapy is maintained, nutritional supplementation alone does not reduce the risk of clinical relapse. However, supplementation was associated with improved quality of life at the end of follow-up. Conversely, patients without nutritional deficiencies at baseline had a lower risk of relapse, suggesting that optimal nutritional status is associated with deeper remission.