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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Refusal to participate in the study.

Presence of residual digestive lesions associated with Crohn's disease (e.g., colonic or perineal involvement) less than one month after ileocecal resection.

Use of antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within the 28 days prior to stool collection.

Patients with cancer of the digestive tract.

Trial population

Patient with a history of ileocecal resection for Crohn's disease.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Microbiota suspension

    Other intervention

    If the patient agrees to participate, the stool sample will be used for both fecal calprotectin analysis (standard care) and the analysis of gut microbiota and short-chain fatty acids (research protocol). The purpose of this stool collection is to address the primary and secondary objectives of the present study.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Association between intestinal inflammatory activity and the carriage rInvestigating the aate of *Pilosibacter rotomagensis

Investigating the association between intestinal inflammatory activity and the carriage rate of \*Pilosibacter rotomagensis following resection for isolated ileal Crohn's disease by measuring fecal calprotectin levels

Time frame
1 day

Secondary outcomes

1

Association between intestinal inflammatory activity and the relative abundance of Pilosibacter rotomagensis

Investigate the association between intestinal inflammatory activity and the relative abundance of Pilosibacter rotomagensis within the microbiota following resection for isolated ileal Crohn's disease by assessing the abundance of Pilosibacter rotomagensis in stool samples

Time frame
1 day
2

Association between fecal carriage of Pilosibacter rotomagensis and clinical recurrence of Crohn's disease

Investigation of the association between fecal carriage of \*Pilosibacter rotomagensis\* and clinical recurrence of Crohn's disease following resection for isolated ileal Crohn's disease by determining the number of clinical recurrences of Crohn's disease

Time frame
1 day
3

Association between intestinal inflammatory activity and fecal short-chain fatty acid abundance

Investigation of the association between intestinal inflammatory activity and fecal short-chain fatty acid abundance following resection for isolated ileal Crohn's disease by assessing the abundance of short-chain fatty acids in the stool.

Time frame
1 day
4

Association between intestinal inflammatory activity and the relative abundance of F. prausnitzii in the microbiota

Investigation of the association between intestinal inflammatory activity and the relative abundance of F. prausnitzii in the microbiota following resection for isolated ileal Crohn's disease by Evaluation of the abundance of F. prausnitzii in stool

Time frame
1 day

Other outcomes

Sponsors and contacts

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