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POP-REMIND
Sponsor study identifier
interventional
575
2 countries
17
Study Start
December 10, 2009
Actual (reported)Primary Completion
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 10, 2009
Actual (reported)March 1, 2018
Actual (reported)March 8, 2018
Actual (reported)December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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.
blood samples, biopsies, and surgical specimen collected in addition to usual practice
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
SART Tilman Hospital
Liège, Belgium
Amiens Hospital
Amiens, 80054, France
Haut-levêque Hospital
Bordeaux, 33, France
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.
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.
Matthieu ALLEZ, Pr
Remind
First Submitted
March 1, 2018
First Posted
March 8, 2018
Study Start
December 10, 2009
Actual (reported)Contact the study team to confirm eligibility.
Clermont-Ferrand Hospital
Clermont-Ferrand, 63003, France
Beaujon Hospital
Clichy, 92110, France
Henri Mondor Hospital
Créteil, France
Kremlin-Bicêtre Hospital
Le Kremlin-Bicêtre, France
Lille Hospital
Lille, 59037, France
Hôpital Nord, CHU Marseille
Marseille, France
Montpellier Hospital
Montpellier, France
Brabois Hospital
Nancy, France
Nantes Hospital
Nantes, 44093, France
Archet 2 Hospital
Nice, 06202, France
Saint Louis Hospital
Paris, 75010, France
Saint Antoine Hospital
Paris, 75012, France
South Lyon Hospital
Pierre-Bénite, 69495, France
Strasbourg Hospital
Strasbourg, France
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Jul;171(1):84-98. doi: 10.1053/j.gastro.2026.01.043. Epub 2026 Feb 24.
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.
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 Aug;171(2):298-313. doi: 10.1053/j.gastro.2026.02.035. Epub 2026 Mar 16.
Primary Completion
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 24, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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