Clinical Research Directory

Effect of Intestinal Carriage of *Pilosibacter Rotomagensis* on Intestinal Inflammatory Activity

Crohn's disease is a chronic inflammatory condition that can affect the entire digestive tract. The terminal ileum is the segment most frequently involved, and approximately one-third of patients present with disease limited to the ileum. In such cases, surgical resection to remove all inflammatory lesions may be performed. This procedure prevents recurrence in about 50% of patients within five years of surgery. The post-operative setting offers a prime opportunity to study the early pathophysiological stages of Crohn's disease and the risk factors for recurrence. While smoking is a well-established risk factor for recurrence, the role of other factors-such as a fistulizing phenotype or a history of small-bowel resection-remains a subject of debate. Meanwhile, the role of the gut microbiota in this process remains largely unclear. Currently, the prevention of post-operative recurrence relies exclusively on smoking cessation and biologic therapies. However, the efficacy of these biologics-particularly anti-TNFα (Tumor Necrosis Factor alpha) agents-is reduced in patients who received prior treatment with these drugs before surgery. Notably, the proportion of such pre-treated patients has risen over the last two decades, reaching 50%. Consequently, there is a need to expand the range of strategies available to prevent post-operative recurrence. A better understanding of host-gut bacteria interactions could help prevent postoperative recurrence. To date, only \*Faecalibacterium prausnitzii\* and Adherent-Invasive \*Escherichia coli\* (AIEC) have been associated with a lower and higher risk of postoperative recurrence, respectively. However, a randomized controlled trial showed that antibiotic treatment aimed at eradicating AIEC was no more effective than a placebo in Crohn's disease. These trial results reinforce the value of a strategy based on identifying anti-inflammatory bacterial species that may play a protective role against postoperative recurrence. \*Pilosibacter rotomagensis\* is a bacterial species recently isolated from humans by the INSERM U1073 team; it may play a key role in intestinal physiology. This species is distinguished by its high capacity to produce short-chain fatty acids-particularly butyrate-and by anti-inflammatory properties observed in various \*in vitro\* cellular models. The hypothesis of this project is that carriage of \*Pilosibacter rotomagensis\* could play a protective role against postoperative recurrence in ileal Crohn's disease.

Cardiovascular Risk in Patients With IBD

In this study our Research Hospital San Donato Policlinic ask your partipation with the aim to evaluate the risk of cardiovascular complication (i.e. stroke, myocardial infarction) in patients with inflammatory bowel disease. Multiple parameters (therapy, disease activity, life style) and investigations (DNA, stool, lab tests) will be evaluate with the support of artificial intelligence methodologies to better define the cardiovascular risk.

The Efficacy and Safety of Infliximab Combination With Azathioprine in Crohn's Disease in Children

The goal of this clinical trial is to investigate whether there are significant differences in the efficacy of infliximab monotherapy and combined azathioprine therapy in treating pediatric Crohn's disease, as well as whether there are differences in the safety of these two treatment regimens during long-term use. The main questions it aims to answer are: Is infliximab combined with azathioprine superior to monotherapy in inducing and maintaining remission of Crohn's disease in children? In long-term treatment, can infliximab combined with azathioprine more effectively reduce disease activity and the occurrence of complications, but the incidence of adverse reactions is not higher than that of monotherapy? Researchers will compare the treatment of infliximab combined with azioprine with that of infliximab monotherapy to assess the efficacy and safety of both in inducing and maintaining remission of Crohn's disease in children. Participants will: Take drug ABC or a placebo every day for 4 months Experimental group: Infliximab, administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter, along with azathioprine, taken orally at 1.5-2.5mg/kg daily. Control group: Infliximab (Remicade), administered intravenously at 5mg/kg every 8 weeks at weeks 0, 2, 6 and thereafter. A comprehensive disease assessment will be conducted at the hospital in the 14th and 54th weeks. Record their symptoms, signs and test results.

Akkermansia Muciniphila Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease

This study aims to evaluate whether the combination of Akkermansia muciniphila with infliximab can improve intestinal mucosal healing in patients with Crohn's disease compared with infliximab alone.