Ileal Crohn's Disease and Post-operative Outcome: Prospective Cohort Study of the REMIND Group

NCT03458195 | Recruiting

• 1 other identifier: POP STUDY - REMIND
• Study Type: interventional
• Target: 575
• Locations: 2 countries
• Sites: 17

Brief Summary

Crohn's disease (CD), a chronic inflammatory process in intestinal segments leads to tissue damage. More than two thirds of CD patients need intestinal resection. Symptomatic clinical recurrence occurs in 60% by 10 years. The principal factors affecting postoperative recurrence are active smoking, penetrating disease, perianal lesions history, prior intestinal resection, small bowel resection extent, and prophylaxis treatment absence. Ileocolonoscopy within one year of surgery can predict clinical recurrence risk. Different therapies are proposed after surgery, to prevent post-operative recurrence : Thiopurines, 6-mercaptopurine (positive for clinical and endoscopic postoperative recurrence prevention), Anti-tumour necrosis factor therapy (anti-TNF), the most effective therapy. Intestinal microbiota acts as a central factor in the CD pathogenesis, and fecal stream role is clearly shown. Various changes in luminal flora with a possible link to local inflammation was also demonstrated. Bacteria associated with postoperative recurrence could be more pathogenic as adherent invasive E coli (AIEC), which could be a pathogen in CD through several mechanisms including increased mucosal colonization, adherence, replication and induction of TNF secretion. Alternatively, postoperative CD recurrence could be linked to a protective commensal species lack, such as Faecalibacterium prausnitzii. Microscopic inflammation occurs as early as 8 days after anastomosis in the neoterminal ileum mucosa. IL6, IL10 and TGFb levels, measured in neoterminal ileum early after surgery are associated with different rates of postoperative recurrence. It suggests cytokines implication in postoperative recurrence. T cells are major players in the intestinal immune response. The presence at time of surgery and persistence of disease inducing T cell clonal expansions could play an important role in post-operative recurrence. The main objective is to define a classification of ileal Crohn's Disease based on data integration on a large cohort of patients.

Conditions

Crohn Disease

Keywords

ileo-caecal resection; post-operative recurrence

Outcome Measures

Primary Outcomes (4)

• Ileal Crohn's disease classification

  Ileal Crohn's disease classification will be performed using data integration (taking into account clinical data, immunological, genetic, microbiota, transcriptome data). A molecular classification will be possible due to this data integration analysis

  surgery time, Time 0

• Postoperative recurrence study

  Rates of endoscopic recurrence as defined by a Rutgeerts score ≥ 1 in patients will be evaluated at the endoscopic exam

  6 months after surgery

• Study of Treatments efficacy to prevent recurrence

  During a clinical visit, scheduled as usual practice 6 months after surgery, clinical data will be collected : treatment modification or optimization, recurrence occurrence. If treament modification or optimization is needed (clinical symptoms or endoscopic recurrence), or complication occurs (abcess, occlusive syndrom, new surgery), patient will be considered as suffering a long-term relapse

  6 months after surgery time

• Identification of biomarkers which could predict postoperative recurrence and response to treatments

  Identification of biomarkers taking into account clinical data, immunological, genetic, microbiota, transcriptome data

  surgery time, Time 0

Study Arms (1)

Crohn's disease patients

EXPERIMENTAL

Patients aged 18 or more, for whom Crohn's disease diagnosis is confirmed and ileum or ileocecal Crohn's disease require surgical resection. in addition to usual practice, a bio-banking (blood samples, biopsies and surgical specimens) is collected.

Other: bio-banking collection

Interventions

bio-banking collection OTHER

blood samples, biopsies, and surgical specimen collected in addition to usual practice

Crohn's disease patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any study-related activities
• A diagnosis of CD, based on clinical, radiologic, endoscopic, or histological evidence.
• Men and women ≥18 years of age
• Required surgical intervention consisting in an ileocecal resection

You may not qualify if:

• Previous history of dysplasia or cancer in the ileum or colon
• Unwillingness or inability to follow the procedures outlined in the protocol
• Pregnant women

Sponsors & Collaborators

• Saint-Louis Hospital, Paris, France: lead

Study Sites (17)

SART Tilman Hospital

Liège, Belgium

RECRUITING

Amiens Hospital

Amiens, 80054, France

RECRUITING

Haut-levêque Hospital

Bordeaux, 33, France

ACTIVE NOT RECRUITING

Clermont-Ferrand Hospital

Clermont-Ferrand, 63003, France

RECRUITING

Beaujon Hospital

Clichy, 92110, France

RECRUITING

Henri Mondor Hospital

Créteil, France

RECRUITING

Kremlin-Bicêtre Hospital

Le Kremlin-Bicêtre, France

RECRUITING

Lille Hospital

Lille, 59037, France

RECRUITING

Hôpital Nord, CHU Marseille

Marseille, France

RECRUITING

Montpellier Hospital

Montpellier, France

RECRUITING

Brabois Hospital

Nancy, France

RECRUITING

Nantes Hospital

Nantes, 44093, France

RECRUITING

Archet 2 Hospital

Nice, 06202, France

RECRUITING

Saint Louis Hospital

Paris, 75010, France

RECRUITING

Saint Antoine Hospital

Paris, 75012, France

RECRUITING

South Lyon Hospital

Pierre-Bénite, 69495, France

RECRUITING

Strasbourg Hospital

Strasbourg, France

ACTIVE NOT RECRUITING

Related Publications (18)

• Sokol H, Brot L, Stefanescu C, Auzolle C, Barnich N, Buisson A, Fumery M, Pariente B, Le Bourhis L, Treton X, Nancey S, Allez M, Seksik P; REMIND Study Group Investigators. Prominence of ileal mucosa-associated microbiota to predict postoperative endoscopic recurrence in Crohn's disease. Gut. 2020 Mar;69(3):462-472. doi: 10.1136/gutjnl-2019-318719. Epub 2019 May 29.

  PMID: 31142586 BACKGROUND

• Auzolle C, Nancey S, Tran-Minh ML, Buisson A, Pariente B, Stefanescu C, Fumery M, Marteau P, Treton X, Hammoudi N; REMIND Study Group Investigators; Jouven X, Seksik P, Allez M. Male gender, active smoking and previous intestinal resection are risk factors for post-operative endoscopic recurrence in Crohn's disease: results from a prospective cohort study. Aliment Pharmacol Ther. 2018 Nov;48(9):924-932. doi: 10.1111/apt.14944. Epub 2018 Aug 20.

  PMID: 30126030 RESULT

• Allez M, Auzolle C, Le Bourhis L, Seksik P. Editorial: predicting recurrence of Crohn's disease after surgical resection-Close to a crystal ball. Authors' reply. Aliment Pharmacol Ther. 2018 Nov;48(10):1157-1158. doi: 10.1111/apt.14998. No abstract available.

  PMID: 30375683 RESULT

• Le Baut G, O'Brien C, Pavli P, Roy M, Seksik P, Treton X, Nancey S, Barnich N, Bezault M, Auzolle C, Cazals-Hatem D, Viala J, Allez M; REMIND GROUP; Hugot JP, Dumay A. Prevalence of Yersinia Species in the Ileum of Crohn's Disease Patients and Controls. Front Cell Infect Microbiol. 2018 Sep 21;8:336. doi: 10.3389/fcimb.2018.00336. eCollection 2018.

  PMID: 30298122 RESULT

• Allez M, Auzolle C, Ngollo M, Bottois H, Chardiny V, Corraliza AM, Salas A, Perez K, Stefanescu C, Nancey S, Buisson A, Pariente B, Fumery M, Sokol H, Treton X, Barnich N, Seksik P, Le Bourhis L; REMIND Study Group. T cell clonal expansions in ileal Crohn's disease are associated with smoking behaviour and postoperative recurrence. Gut. 2019 Nov;68(11):1961-1970. doi: 10.1136/gutjnl-2018-317878. Epub 2019 Feb 12.

  PMID: 30792246 RESULT

• Hammoudi N, Cazals-Hatem D, Auzolle C, Gardair C, Ngollo M, Bottois H, Nancey S, Pariente B, Buisson A, Treton X, Fumery M, Bezault M, Seksik P, Le Bourhis L; REMIND Study Group Investigators; Flejou JF, Allez M. Association Between Microscopic Lesions at Ileal Resection Margin and Recurrence After Surgery in Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2020 Jan;18(1):141-149.e2. doi: 10.1016/j.cgh.2019.04.045. Epub 2019 Apr 28.

  PMID: 31042575 RESULT

• Fumery M, Seksik P, Auzolle C, Munoz-Bongrand N, Gornet JM, Boschetti G, Cotte E, Buisson A, Dubois A, Pariente B, Zerbib P, Chafai N, Stefanescu C, Panis Y, Marteau P, Pautrat K, Sabbagh C, Filippi J, Chevrier M, Houze P, Jouven X, Treton X, Allez M; REMIND study group investigators. Postoperative Complications after Ileocecal Resection in Crohn's Disease: A Prospective Study From the REMIND Group. Am J Gastroenterol. 2017 Feb;112(2):337-345. doi: 10.1038/ajg.2016.541. Epub 2016 Dec 13.

  PMID: 27958285 RESULT

• Khaloian S, Rath E, Hammoudi N, Gleisinger E, Blutke A, Giesbertz P, Berger E, Metwaly A, Waldschmitt N, Allez M, Haller D. Mitochondrial impairment drives intestinal stem cell transition into dysfunctional Paneth cells predicting Crohn's disease recurrence. Gut. 2020 Nov;69(11):1939-1951. doi: 10.1136/gutjnl-2019-319514. Epub 2020 Feb 28.

  PMID: 32111634 RESULT

• Perez K, Ngollo M, Rabinowitz K, Hammoudi N, Seksik P, Xavier RJ, Daly MJ, Dotan I, Le Bourhis L, Allez M. Meta-Analysis of IBD Gut Samples Gene Expression Identifies Specific Markers of Ileal and Colonic Diseases. Inflamm Bowel Dis. 2022 May 4;28(5):775-782. doi: 10.1093/ibd/izab311.

  PMID: 34928348 RESULT

• Ngollo M, Perez K, Hammoudi N, Gorelik Y, Delord M, Auzolle C, Bottois H, Cazals-Hatem D, Bezault M, Nancey S, Nachury M, Treton X, Fumery M, Buisson A, Barnich N, Seksik P; REMIND Study Group Investigators; Shen-Orr SS, Le Bourhis L, Allez M. Identification of Gene Expression Profiles Associated with an Increased Risk of Post-Operative Recurrence in Crohn's Disease. J Crohns Colitis. 2022 Aug 30;16(8):1269-1280. doi: 10.1093/ecco-jcc/jjac021.

  PMID: 35143619 RESULT

• Buisson A, Sokol H, Hammoudi N, Nancey S, Treton X, Nachury M, Fumery M, Hebuterne X, Rodrigues M, Hugot JP, Boschetti G, Stefanescu C, Wils P, Seksik P, Le Bourhis L, Bezault M, Sauvanet P, Pereira B, Allez M, Barnich N; Remind study group. Role of adherent and invasive Escherichia coli in Crohn's disease: lessons from the postoperative recurrence model. Gut. 2023 Jan;72(1):39-48. doi: 10.1136/gutjnl-2021-325971. Epub 2022 Mar 31.

  PMID: 35361684 RESULT

• Julien C, Anakok E, Treton X, Nachury M, Nancey S, Buisson A, Fumery M, Filippi J, Maggiori L, Panis Y, Zerbib P, Francois Y, Dubois A, Sabbagh C, Rahili A, Seksik P, Allez M, Lefevre JH; REMIND Study Group Investigators; Le Corff S, Bonnet A, Beyer-Berjot L, Sokol H. Impact of the Ileal Microbiota on Surgical Site Infections in Crohn's Disease: A Nationwide Prospective Cohort. J Crohns Colitis. 2022 Aug 30;16(8):1211-1221. doi: 10.1093/ecco-jcc/jjac026.

  PMID: 35218661 RESULT

• Chervy M, Sivignon A, Dambrine F, Buisson A, Sauvanet P, Godfraind C, Allez M, Le Bourhis L, The Remind Group, Barnich N, Denizot J. Epigenetic master regulators HDAC1 and HDAC5 control pathobiont Enterobacteria colonization in ileal mucosa of Crohn's disease patients. Gut Microbes. 2022 Jan-Dec;14(1):2127444. doi: 10.1080/19490976.2022.2127444.

  PMID: 36175163 RESULT

• Hammoudi N, Hamoudi S, Bonnereau J, Bottois H, Perez K, Bezault M, Hassid D, Chardiny V, Grand C, Gergaud B, Bonnet J, Chedouba L, Tran Minh ML, Gornet JM, Baudry C, Corte H, Maggiori L, Toubert A, McBride J, Brochier C, Neighbors M, Le Bourhis L, Allez M. Autologous organoid co-culture model reveals T cell-driven epithelial cell death in Crohn's Disease. Front Immunol. 2022 Nov 10;13:1008456. doi: 10.3389/fimmu.2022.1008456. eCollection 2022.

  PMID: 36439157 RESULT

• Hammoudi N, Auzolle C, Tran Minh ML, Boschetti G, Bezault M, Buisson A, Pariente B, Treton X, Seksik P, Fumery M, Le Bourhis L, Nancey S, Allez M. Postoperative Endoscopic Recurrence on the Neoterminal Ileum But Not on the Anastomosis Is Mainly Driving Long-Term Outcomes in Crohn's Disease. Am J Gastroenterol. 2020 Jul;115(7):1084-1093. doi: 10.14309/ajg.0000000000000638.

  PMID: 32618659 RESULT

• Dubois L, Chaussard A, Seksik P, Nancey S, Nachury M, Treton X, Buisson A, Carbonnel F, Fumery M, Peyrin-Biroulet L, Boureille A, Hebuterne X, Serrero M, Louis E, Blanc P, Brot L, Rolhion N, Vermeire S, Manichanh C, Fossmark R, Bezault M, Uzzan M; REMIND Group; Allez M, Sokol H. Uncovering the Dynamics of Mucosa-Associated Microbiota in Postoperative Recurrence of Crohn's Disease. Gastroenterology. 2026 Feb 24:S0016-5085(26)00147-2. doi: 10.1053/j.gastro.2026.01.043. Online ahead of print.

  PMID: 41747778 RESULT

• Allez M, Bak MTJ, Brand S, Diebakate-Scordamaglia L, Capelle E, Seksik P, Nancey S, Gornet JM, Buisson A, Carbonnel F, Peyrin-Biroulet L, Louis E, Hebuterne X, Serrero M, Bourreille A, Treton X, Wils P, Fumery M, Blanc P, Uzzan M, Sokol H, Barnich N, Kirchgesner J, Colombel JF, Maggiori L, Bezault M, Silverberg MS, De Vries AC, Lambert J, Hammoudi N. Development and external validation of a predictive model for postoperative recurrence of Crohn's disease in the biologic era. Clin Gastroenterol Hepatol. 2026 Mar 27:S1542-3565(26)00220-X. doi: 10.1016/j.cgh.2026.03.015. Online ahead of print.

  PMID: 41905522 RESULT

• Verstockt S, Schwarzler J, Willeit P, Bislenghi G, Meyer M, Mayr L, Machiels K, De Hertogh G, Lenfant M, Scheffauer L, Grabherr F, Jans DS, Abdurahiman S, Cleynen I, Jukic A, Zundel L, Moser P, Forer L, Witsch-Baumgartner M, Ferrante M, Sabino J, D'Hoore A, Hess M, Kaser A, Blumberg RS, Koch R, Le Bourhis L, Hammoudi N, Cazals-Hatem D, Vermeire S, Tilg H, Allez M, Verstockt B, Adolph TE. Identification of a Druggable Target That Predicts Postoperative Crohn's Disease Recurrence. Gastroenterology. 2026 Mar 16:S0016-5085(26)00233-7. doi: 10.1053/j.gastro.2026.02.035. Online ahead of print.

  PMID: 41850538 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Matthieu ALLEZ, Pr

  Remind

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthieu ALLEZ, Pr

CONTACT

+33(1) 42 49 95 75; Matthieu.allez@aphp.fr

Philippe SEKSIK, Pr

CONTACT

+33(1) 49 28 31 62; Philippe.seksik@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr Matthieu Allez

Model Details: Patients aged 18 or more, for whom Crohn's disease diagnosis is confirmed and ileum or ileocecal Crohn's disease require surgical resection. in addition to usual practice, a bio-banking (blood samples, biopsies and surgical specimens) is collected.

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 8, 2018
• Study Start: December 10, 2009
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2035
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (16)