[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659887":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":51,"studyPopulation":52,"armGroups":47,"interventions":53,"overallOfficials":57,"centralContacts":61,"locations":71,"responsibleParty":88,"collaborators":47,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":47,"enrollmentInfo":100,"targetDuration":103,"studyType":104,"phases":47,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":111,"whyStopped":47,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University Hospital, Rouen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"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","1 day",[14,17,20,23,26,29,32,34,37,39,41,43,45],{"measure":15,"description":16,"timeFrame":12},"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",{"measure":18,"description":19,"timeFrame":12},"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",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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",{"measure":27,"description":28,"timeFrame":12},"Association between intestinal inflammatory activity and the relative abundance of AIEC within the microbiota","Investigation of the association between intestinal inflammatory activity and the relative abundance of AIEC within the microbiota following resection for isolated ileal Crohn's disease by measuring the abundance of AIEC in the stool. AIEC stands for Adherent-Invasive Escherichia coli.",{"measure":30,"description":31,"timeFrame":12},"Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.","Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating alpha-diversity indices (observed richness,)",{"measure":30,"description":33,"timeFrame":12},"Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating Beta-diversity indices (Bray-Curtis dissimilarity index and Jaccard distance)",{"measure":35,"description":36,"timeFrame":12},"Association between intestinal inflammatory activity and the taxonomic composition of the gut microbiota.","Investigation of the association between intestinal inflammatory activity and the taxonomic composition of the gut microbiota.by evaluating the relative abundance of the bacterial taxa making up the gut microbiota.",{"measure":30,"description":38,"timeFrame":12},"Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating alpha-diversity indices (Simpson Indice). The Simpson index is a measure of gut microbiota diversity. It therefore takes into account two elements:\n\n1. richness: how many bacterial taxa are present;\n2. evenness: how abundances are distributed among these taxa (in %).",{"measure":30,"description":40,"timeFrame":12},"Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating alpha-diversity indices (Shannon indice). The Shannon index is an alpha-diversity index used to measure gut microbiota diversity. It specifies how many types of bacteria are present and the extent to which their abundances are balanced (In %)",{"measure":30,"description":42,"timeFrame":12},"Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating alpha-diversity indices (Pielou indice). Pielou's index measures the evenness of a microbiota.It makes it possible to determine whether the various bacterial species are present in relatively balanced proportions. Pielou's index is calculated from the Shannon index:\n\nJ = H' \u002F log(S) where: H' = Shannon index; S = number of observed taxa (richness).\n\nThe value generally ranges from 0 to 1:\n\n1 → all species are present in equal proportions; close to 0 → one or a few species are strongly dominant.",{"measure":30,"description":44,"timeFrame":12},"Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating the beta-diversity index (Bray-Curtis dissimilarity index). Bray-Curtis is an index that measures the difference in composition between two microbiota. The two microbiota are identical → Bray-Curtis = 0. The microbiota are completely different → Bray-Curtis = 1.",{"measure":30,"description":46,"timeFrame":12},"Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating the beta-diversity index (Jaccard distance index). The Jaccard distance index is a measure of beta-diversity; it is used to compare the composition of two microbiota. The Jaccard distance generally ranges from 0 to 1:\n\n0 → the two microbiota share the same taxa;\n\n1 → no taxa in common.",null,{"allocation":47,"interventionModel":47,"interventionModelDescription":47,"primaryPurpose":47,"observationalModel":49,"timePerspective":50,"maskingInfo":47},"CASE_ONLY","PROSPECTIVE","To explore this hypothesis, we will conduct a single-center, cross-sectional study investigating the association between \\*Pilosibacter rotomagensis\\* carriage and intestinal inflammatory activity following resection for isolated ileal Crohn's disease. Crohn's disease inflammatory activity will be assessed by measuring fecal calprotectin, a non-invasive inflammatory marker specific to intestinal inflammation that is used in routine clinical practice. Disease recurrence will be defined as the occurrence of any of the following events during the postoperative period: (1) endoscopic recurrence (defined by a Rutgeerts score ≥ 2); (2) a new surgical procedure related to Crohn's disease; or (3) the initiation or modification of biologic therapy at least 6 months after ileocecal resection. Furthermore, given the cross-sectional nature of the study, it would be difficult to establish a causal relationship-whether cause or consequence-between recurrence and bacterial carriage. Therefore, the association with inflammatory activity (fecal calprotectin) in the postoperative setting will be analyzed while adjusting for the following clinical parameters: smoking status at the time of sampling (non-smoker, former smoker, current smoker), complicated phenotype (defined as a history of fistulizing or stenosing complications during the course of Crohn's disease), and the time elapsed since surgery. The expected benefit of this study is to establish an initial clinical rationale regarding the role of this bacterium in the process of postoperative recurrence of Crohn's disease, by examining intestinal inflammation and its marker, fecal calprotectin. Consequently, this study could justify a multicenter, longitudinal, observational research protocol to investigate postoperative carriage of \\*Pilosibacter rotomagensis\\* and longitudinally track clinical recurrences of Crohn's disease. The ultimate goal of this line of research would be to pave the way for interventional studies aimed at preventing postoperative recurrence through oral supplementation with this bacterium. Finally, this study is part of a cross-disciplinary initiative to translate preclinical discoveries made by a research unit at the University of Rouen-a partner of the University Hospital-into clinical application.","Patient with a history of ileocecal resection for Crohn's disease.",[54],{"type":6,"name":55,"description":56,"armGroupLabels":47,"otherNames":47},"Microbiota suspension","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.",[58],{"name":59,"affiliation":5,"role":60},"Nicolas NR RICHARD, Doctor","STUDY_DIRECTOR",[62,68],{"name":63,"role":64,"phone":65,"phoneExt":66,"email":67},"Nabila NL LAAJAIL, Director","CONTACT","02 32 88 82 65","+33","Nabila.Laajail@chu-rouen.fr",{"name":69,"role":64,"phone":65,"phoneExt":66,"email":70},"Vincent VF FERRANTI, Arc","vincent.ferranti@chu-rouen.fr",[72],{"facility":73,"status":47,"city":74,"state":47,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"University Rouen Hospital","Rouen","76031","France","FR",{"type":79,"coordinates":80},"Point",[81,82],1.09932,49.44313,{"lat":82,"lon":81},[85],{"name":59,"role":64,"phone":86,"phoneExt":66,"email":87},"02 32 88 67 07","Nicolas.Richard@chu-rouen.fr",{"type":89,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100659887","effect-of-intestinal-carriage-of-pilosibacter-rotomagensis-on-intestinal-inflammatory-activity-100659887",false,"NCT07871383","Effect of Intestinal Carriage of *Pilosibacter Rotomagensis* on Intestinal Inflammatory Activity","Effect of Intestinal Carriage of *Pilosibacter Rotomagensis* on Intestinal Inflammatory Activity in the Postoperative Setting of Crohn's Disease.","ProsPec","Inclusion Criteria:\n\n* Patient aged 18 years or older\n* Patient with a history of ileocecal resection for Crohn's disease.\n* Patient with isolated ileal Crohn's disease at the time of ileocecal resection surgery.\n\nExclusion Criteria:\n\n* Refusal to participate in the study.\n* Presence of residual digestive lesions associated with Crohn's disease (e.g., colonic or perineal involvement) less than one month after ileocecal resection.\n* Use of antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within the 28 days prior to stool collection.\n* Patients with cancer of the digestive tract.\n* Pregnant patients.","ALL","18 Years",{"count":101,"type":102},116,"ESTIMATED","1 Day","OBSERVATIONAL","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.\n\nThe 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.\n\n\\*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.\n\nThe hypothesis of this project is that carriage of \\*Pilosibacter rotomagensis\\* could play a protective role against postoperative recurrence in ileal Crohn's disease.",[107],"Crohn's Diseases",[109,110],"Pilosibacter rotomagensis","intestinal inflammatory activity","NOT_YET_RECRUITING","2026-09-30",{"date":114,"type":115},"2026-10-13","ACTUAL",{"date":117,"type":102},"2026-10-01",{"date":119,"type":102},"2028-10-30",{"name":5,"class":6},1]