Gut bacterium Pilosibacter rotomagensis and bowel inflammation after Crohn's disease surgery

Trial details

Who runs it

University Hospital, Rouen

Trial code

NCT07871383

Record updated

13 October 2026

Original description

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.Read full original descriptionShow less

Effect of Intestinal Carriage of *Pilosibacter Rotomagensis* on Intestinal Inflammatory Activity in the Postoperative Setting of Crohn's Disease.

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.

Inclusion: Patient aged 18 years or older; Patient with a history of ileocecal resection for Crohn's disease; Patient with isolated ileal Crohn's disease at the time of ileocecal resection surgery.

Exclusion: Use of antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within the 28 days prior to stool collection; Presence of residual digestive lesions associated with Crohn's disease (e.g., colonic or perineal involvement) less than one month after ileocecal resection; Patients with cancer of the digestive tract; Refusal to participate in the study; Pregnant patients.

ClinicalTrials.gov NCT07871383