Effect of Modulen vs budesonide on clinical response and mucosal healing in Crohn's patients

BACKGROUND Mucosal healing has become an important goal of Crohn’s disease (CD) treatments. Modulen, enriched with transforming growth factor-beta 2, and budesonide are commonly accepted treatments for mild-moderate CD. However, their effects on the small bowel (SB) mucosa remain underexplored. AIM To prospectively assess clinical and mucosal responses to Modulen vs budesonide in adults with CD, using SB capsule endoscopy. METHODS Thirty patients were divided into two groups: Modulen + home-based diet (21 patients) and budesonide (9 patients) for an eight-week intervention followed by four weeks of follow-up. Clinical, laboratory, and endoscopic responses were evaluated. The mucosal changes were assessed through SB capsule endoscopy. RESULTS Results indicated significant clinical improvement in the Modulen group with reduced CD activity index (P = 0.041) and improved inflammatory bowel disease questionnaire score (P = 0.016). Moreover, Modulen was associated with a significant SB mucosal improvement, evidenced by a decrease in Lewis score (P = 0.027). No significant changes were observed in calprotectin or other laboratory parameters. Conversely, budesonide exhibited more modest clinical effects, but it improved calprotectin, hemoglobin, and C-reactive protein levels (P = 0.051, P = 0.014, and P = 0.038, respectively). The capsule endoscopy did not reveal a significant mucosal response in the budesonide group. CONCLUSION Both interventions have a role in CD treatment. Yet, their effects differ and may complement each other: Modulen yields clinical and mucosal improvements, while budesonide primarily leads mainly to laboratory improvements.