NCT07871383Toborzás még nem indult
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.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 13.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 116 (tervezett)
- Első benyújtás
- 2026. szept. 30.
- Kezdés
- 2026. okt. 1.
- Elsődleges befejezés
- 2028. okt. 1.
- Fő szponzor
- University Hospital, Rouen
- Betegségek
- Crohn-betegség
- NCT-szám
- NCT07871383
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 116
- 2026. okt. 1. és az elsődleges befejezés (2028. okt. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Use of antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within the 28 days prior to stool collection.
Más betegség
- 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.
Egyéb
- Refusal to participate in the study.
- Pregnant patients.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University Rouen Hospital | Rouen | Franciaország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.