An interventional study of bio-banking collection in Crohn Disease, sponsored by Saint-Louis Hospital, Paris, France. Recruiting at 17 sites in 2 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Saint-Louis Hospital, Paris, France · Not applicable, Interventional, and Basic science
Among 316 studies in Crohn Disease with a site in France — 80 open to participants now, 104 under way, 29 of them phase 3. Crohn Disease · France.
Among the 316 studies in Crohn Disease with a site in France, this one is the 30th largest by planned enrollment of the 228 interventional ones that give a count, is one of 4 that started in 2009, is one of 62 with no phase, reaches primary completion later than 97 of the 103 other live ones, and was the 156th registered.
1,992 studies on the registry are indexed under Crohn Disease; 477 are open to participants now.
Browse Crohn Disease studies →80 of the 316 studies in Crohn Disease with a site in France are open now. Recruiting first, the newest first:
Central Hospital, Nancy, France · Sites in France
Ages 18+
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Sites in France
Ages 18+
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Sites in France
Ages 18+
Janssen Research & Development, LLC · Sites in France, United States, Argentina and 27 more countries
Ages 18+
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Sites in France
Ages 18–75
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 353 Crohn Disease studies recruiting now, 154 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 95 take children under 18; 56 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
316 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 64 · Phase 3 86 · Phase 4 16
First in 1990; this study’s year is marked. 4 started in 2009.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 575 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Median enrollment 147 across the 228 interventional studies, 240 across the 87 observational. Of the 194 that completed or were terminated, 78 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
150 of 316 have an industry lead sponsor. The 10 most frequent:
Saint-Louis Hospital, Paris, France is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Saint-Louis Hospital, Paris, France has 1 study filed under Crohn Disease — fewer than ten, so there is no comparison to draw.
33 of the studies in Crohn Disease with a site in France that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04777656Phase 3Assistance Publique - Hôpitaux de ParisUse of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. | 2026-11 |
| NCT05347095Phase 3Janssen-Cilag Ltd.A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease | 2027-03-25 |
| NCT04997733Phase 3Assistance Publique - Hôpitaux de ParisFecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal | 2027-05-22 |
| NCT06408935Phase 3Janssen-Cilag Ltd.Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients | 2027-06-08 |
| NCT06227910Phase 3TakedaA Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease | 2027-06-08 |
Add all 33 to your calendar (.ics) → With an account.
Among the 316 studies in Crohn Disease with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Crohn's Disease is a major health issue with a complex etiology and despite available medical treatment, patients endure poor quality of life. The disease 's characterization on a molecular level will allow for a better management of patients treatment. To do so, the strategy is to integrate precise prospective clinical records with extensive biological data in a large cohort of patients.
All the clinical centers, participating to the study, include patients, with a tight collaboration between Gastroenterology and Surgery departments. Demographics and clinical parameters are collected in an eCRF.
Inclusion of patients is performed, before a scheduled ileocecal resection or ileal resection, and after eligibility criteria checking, and consent form signature. During surgery, several samples are collected : blood samples, mucosal biopsies, and surgical specimens. As usual practice, post-operative treatment will be prescribed at investigator's discretion, with help of a pre-established algorithm. Then, an endoscopic exam is scheduled, at least 6 months after surgery, or at least 6 months after intestine continuity restoration, in case of temporary stoma. Several samples are also collected during this exam (blood, ileal and colon biopsies).
At the same time as these 2 visits, clinical data regarding medical history, CD history, surgical history, treatments history, post-operative treatment if prescribed, treatments history between surgery and colonoscopy 6 months later, endoscopic score. Clinical data are also collected 18 months after surgery during a scheduled visit organized as usual practice, for long-term study : Clinical relapse, surgical recurrence, change in the therapy, hospitalizations and complications A patient has achieved the study after the endoscopic exam.
Several studies will be performed along the cohort setting-up:
Samples analyses are performed by dedicated research centers: DNA, and RNA extraction for transcriptome analysis, Micobiota analysis, Lipids analysis, AIEC analysis :
Histological analyzes: Analyzis of the structure and inflammatory status of intestinal tissue of patients of the cohort, particularly at the ileal limit of the surgical specimens.
Molecular Biology: Whole genome expression analyses are performed using microarray and followed by Gene Ontology and clustering analyses.
Microbiology:
Adherent Invasive E.Coli (AIEC): The search for AIEC bacteria is carried out by culturing and investigating the characteristics of adhesion, invasion in Int-407 cells, and survival within THP-1 macrophages.
Microbiota: Bacterial composition of the ileal mucosa associated microbiota is analyzed at time of surgery using 16S (MiSeq, Illumina) sequencing. The obtained sequences are analyzed using the Qiime pipeline to assess composition, alpha and beta diversity.
Immunology:
Phenotype of mucosal and peripheral immune cells: Immune cells are extracted from blood and fresh mucosal tissues. The phenotype of these cells is analyzed by cytometry.
T cell repertoire: T cell receptor analysis on DNA extracted from biopsies is performed by next generation sequencing (Adaptive Biotechnology Inc., Seattle, Washington, USA). It is hypothesized that the persistence of these clonal expansions could be linked to the presence of specific microbial antigens.
Data Integration: The aim is to predict post-operative recurrence at M6. Integration of all datasets will explore the ability to predict post-operative recurrence. This will also allow to establish a molecular classification of CD, similar to what is already available in the oncology field. It will also be tried to find regulatory genes of the intestinal mucosa ("hubs"), using causal models (Bayesian networks) and co-expression networks (WCGNA). These findings could help drive potential innovative therapy for the treatment of CD.
The comparative analysis of the mucosa-associated transcriptome and microbiome will be performed. This could allow to elucidate the relations between bacteria and the intestinal mucosa, and to uncover pathways implicated in the bacteria-mucosa dialog. The correlations between certain groups of bacteria and the activation of a number of genes will be looked at. And genes known to play a role in the interaction between the microbiome and the mucosa will be specifically studied (MUC, DEF, REG, NOD2, …).
Lastly, once the patient genotypes will be available, an analysis of the genome together with the transcriptome and the relationship between genotype, transcriptome, and microbiome will be performed.
This analysis should help to robustly identify major pathways involved in intestinal inflammation, study the role played by genetics, and the impact on the gut microbiome. And finally to correlate these results with carefully curated clinical data: relapse/remission, post-operative recurrence, efficacy of post-operative therapies (anti TNF agents, ustekinumab).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
blood samples, biopsies, and surgical specimen collected in addition to usual practice
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: surgery time, Time 0
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
Started Dec 2009 (actual). Primary completion is estimated for Dec 2030, 252 months after the start.
Of 288 non-industry interventional studies with no phase under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 67. This study's planned 252 months is above that.
Counting every sponsor, half of 300 studies reached it within 45 months; a quarter within 21 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
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Saint-Louis Hospital, Paris, France