Research Projects
IBD National Study Group meeting at the ECCO Congress
Since IBD National Study Groups often come up with solid clinical research questions but face problems with recruiting a decent number of patients, the Clinical Research Committee of ECCO (ClinCom) decided to organise a meeting for representatives of European IBD National Study Groups to meet and to exchange views on study projects. The 1st edition of the IBD National Study Group meeting took place at the ECCO Congress 2016 Amsterdam, with the clear aim to support the collaboration among study groups. Following the successful experience, the IBD National Study Group meeting now takes place on a yearly basis, at the ECCO Congress.
Prior to the meeting, a call for study proposals is sent to the IBD Community, to give investigators the opportunity to present their study projects directly to representatives of IBD National Study Groups, to challenge their ideas and foster interest. Each protocol received goes through a free and thorough assessment in two stages (see details in section “Review of Study Protocol: A Two-Stage Process).
Which kind of studies are presented at the IBD National Study Group meeting?
- Multicentric studies, executed predominantly in Europe
- Studies with simple and practical designs, with the goal to recruit a high number of patients
- Observational, non-interventional and retrospective studies. Randomised clinical trials are not recommended as these studies generally require a highly complex design
- Studies proposed by independent researchers (investigation must be independent of industry interests)
The new Call for the Research Projects 2025 is now open.
Please see all the information by clicking the button below.
Deadline postponed to November 11, 2024
Submit your project via email at This email address is being protected from spambots. You need JavaScript enabled to view it.
Review of study protocol: A two-stage process
The assessment of a clinical research protocol encompasses a two-stage process. During the first stage, applicants are called upon to provide a study synopsis including background, design, objectives, outcome parameters, major inclusion and exclusion criteria, statistics, and co-variates not exceeding 4 pages. The first stage’s template is sent by the ECCO Office to the interested submitters upon request, once the call is issued.
Once this first stage application is submitted, the project is reviewed by ClinCom who decides to either support or decline the presentation at the National Study Group Meeting. After the meeting, the PI is invited to submit a full protocol (2nd stage) taking into account the feedback given during the IBD National Study Group meeting. A 2nd stage template is sent by the ECCO Office to the PI.
After the review and approval of the 2nd stage protocol by ClinCom and by the ECCO Governing Board, ECCO offers to support the dissemination of a call to participate to the study project among the IBD Community, to support the recruitment of centres. ECCO does not provide any financial or logistical support to studies. The review by ClinCom of a study protocol is not an ECCO endorsement to the project. It is not allowed to use ECCO’s name and logo to promote a study. ClinCom’s support should be acknowledged in any publication.
Should you have any questions, please contact the ECCO Office (This email address is being protected from spambots. You need JavaScript enabled to view it.)
Open research studies
International, Multi-centre, Retrospective Cohort Study on Morbidity, Frequency Rates and Timings of Surgical Interventions for Ulcerative Colitis
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| Project leaders: |
Mr Orestis Argyriou (Research fellow) |
| Purpose and outcome: |
This study intends to serve as a snapshot of the current practices in surgery for ulcerative colitis (UC) in Europe, by holistically assessing patients’ surgical journey, starting from the index subtotal colectomy. The main aims of the study are to:
To achieve the above, the main outcome parameters that will be assessed, are:
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| Deadline to Participate: |
October 11, 2024 |
| Target group: |
Collaborators/Centre inclusion criteria
Patient inclusion criteria
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| Invitation Letter: |
Maintenance therapy after an episode of steroidresponsive Acute Severe Ulcerative Colitis: what is the best strategy?
| Project leaders: |
Ana Catarina Bravo, Joana Revés, Catarina Frias Gomes, Joana Torres |
| Purpose and outcome: |
Purpose: study the course of steroid-responsive ASUC patients, stratified by the type of medical therapy offered (advanced therapy vs 5 ASA/IMM).
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| Deadline to Participate: |
October 11, 2024 |
| Target group: | Adult patients with an ASUC episode according to Truelove and Witts Criteria who responded to IV steroids according to Oxford Criteria, between 01/01/2010 and 31/12/2021. |
| Invitation Letter: |
HEmorrhoidAl Disease in Inflammatory Bowel Disease (HEAD-IBD-II): A Multicentre Prospective Cohort Study
| Project leaders: |
Ugo Grossi, Gaetano Gallo, Carla Felice |
| Purpose and outcome: | To evaluate the safety and effectiveness of surgical treatments for hemorrhoidal disease in a large multicentre cohort of IBD patients based on clinical and surgical outcomes |
| Deadline to Participate: |
October 11, 2024 |
| Target group: | Adults with a current diagnosis of Crohn's disease or ulcerative colitis at the time of surgery for hemorrhoidal disease |
| Invitation Letter: |
Sequencing JAK-inhibitors in ulcerative colitis: effectiveness and safety of switching within treatment class
| Project leaders: |
Tommaso Innocenti, MD, PhD student1; Gabriele Dragoni, MD, PhD1; Jurij Hanžel, MD, PhD2; Triana Lobaton, MD, PhD3
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| Purpose and outcome: |
Rationale: Treatment failure remains a significant obstacle in the management of patients with ulcerative colitis, despite many new medications have been released. Switching within drug class is a valuable option for patients who lost response to an anti-TNF, but this is generally not recommended for patients with a primary non-response to a drug of the same class. However, less is known about the effectiveness and safety of cycling JAK-inhibitors within drug class in ulcerative colitis, although this is supported by some data in rheumatology. The aim of this retrospective multicentre European real-world study is to assess the effectiveness and safety of within treatment class switch for JAK-inhibitors in patients with ulcerative colitis having already been treated with a JAK-inhibitor. Primary outcome: steroid-free clinical remission after a 12-week treatment with a second JAK-inhibitor in patients previously exposed to a JAK-inhibitor. Secondary outcomes: clinical response at 12, 26 and 52 weeks; steroid-free clinical remission at 26 and 52 weeks; endoscopic improvement/remission at 26 and 52 weeks; CRP normalisation and biochemical remission at 12, 26 and 52 weeks; treatment persistence; start of a 3rd JAK inhibitor in patients who stop treatment. Safety outcomes: serious adverse events, (colectomy, IBD-related or non-related hospitalisation, malignancy, death), infections including Herpes Zoster reactivations, major adverse cardiac events, abnormalities of the blood lipid panel and/or need for statins, abnormalities of the whole blood count, venous thrombo-embolic events, and acne |
| Deadline to Participate: |
October 11, 2024 |
| Target group: |
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| Invitation Letter |
EVOKE - Evaluation of the long-term outcomes of Crohn’s disease complicating intra-abdominal abscess - retrospective, multicentre cohort study
| Project leaders: |
Prof. Tamás Molnár, MD, PhD principal investigator; Péter Bacsur, MD, PhD Student |
| Purpose and outcome: |
The global aim of the study to assess the efficacy and safety of elective surgical intervention of intra-abdominal abscess compared to pharmacotherapeutic management after successful PD in CD patients. The primary outcome is abscess recurrence, defined as the development of an enhancing fluid collection at the same site as the initial lesion after documented resolution. Secondary outcomes are: All intestinal stoma rate defined as a need of a new stoma during FU connected to resection due to abdominal abscess. Permanent intestinal stoma rate, defined as a need of a new permanent stoma during FU connected to resection due to abdominal abscess, assessed at the day of the operation by colorectal surgeon. Post-procedural (PD and surgery) complications rate. Drain drop out, drain closure, catheter associated infection, surgical site infections etc. Surgery associated complications are defined the occurrence of any complications within 30 days after surgery. Adverse events. Severe infection, sepsis, thromboembolism etc |
| Deadline to Participate: |
October 11, 2024 |
| Target group: | Participation is open to all IBD centers with a medium-high IBD incidence who has retrospective data of CD patients complicating simplex intra-abdominal abscess and willingness to collect and share it. |
| Invitation Letter: |
Feasibility and safety of endoscopic submucosal dissection in inflammatory bowel disease: a multicenter European retrospective analysis (ESDEUR-IBD)
| Project leaders: |
María José García1, MD; Miguel Fraile2, PhD
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| Purpose and outcome: |
Rational: Colectomy is the main treatment for dysplastic lesions. However, since the development of advanced endoscopic techniques, the management of dysplasia is evolving. Endoscopic resection and endoscopic submucosal resection have been suggested in selected cases and referral centres. However, the feasibility and safety of this technique in IBD patients is still lacking. Purpose: The purpose of the study is to obtain information about the feasibility of endoscopic submucosal dissection (ESD) and colectomy rate due to ESD failure in inflammatory bowel disease (IBD) patients. Primary outcome:
Secondary outcomes:
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| Deadline to Participate: |
October 11, 2024 |
| Target group: |
Target group:
Inclusion criteria:
Exclusion criteria:
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| Invitation Letter: |
Assessing the effect of newer treatment molecules for IBD on extra- intestinal manifestations and concurrent immune mediated inflammatory diseases
| Project leaders: |
Dr. Marie Truyens1 1 Department of Gastroenterology, University hospital Ghent, Belgium |
| Purpose and outcome: | The aim of the current project is to assess the response and remission rates of extra-intestinal manifestations (EIMs) and immune mediated inflammatory disorders (IMIDs) after initiation of a JAK-inhibitor or anti-IL23 treatment for IBD. |
| Deadline to Participate: |
October 11, 2024 |
| Target group: | All IBD centres with information on the evolution of EIMs and IMIDs during treatment with JAK- and IL-23 inhibitors for IBD. |
| Invitation Letter: |
Evaluation of organizational and healthcare provider level readiness in European IBD centres for outcomes-based quality improvement cycles
| Project leaders: |
Mariam Ali |
| Purpose and outcome: |
This study aims to assess how patient care outcomes are used to improve the quality of care. We also examine whether key resources needed to monitor and implement these outcomes for quality improvement are available in European IBD centres. Finally, we evaluate the association between characteristics of IBD centres and healthcare professionals to the successful implementation of outcomes-based quality improvement. The results of this study will provide insight into the current state of outcomes-based quality improvement in Europe and identify factors associated with successful implementation. |
| Deadline to Participate: |
October 11, 2024 |
| Target group: | Survey: IBD Gastroenterologists from European IBD centres |
| Invitation Letter: |
Ongoing - Prior Years
Fidaxomicin for Clostridium difficile Infection in IBD: a multicenter retrospective cohort study
| Project leaders: |
Prof. Flavio Caprioli, Dr. Daniele Noviello |
| Purpose and outcome: |
Patients with inflammatory bowel disease (IBD) have an increased risk of Clostridium difficile Infection (CDI) and IBD patients with CDI have a higher rate of IBD exacerbation. In the general population, oral vancomycin and fidaxomicin are equally effective in treating CDI though recurrence rates are lower for fidaxomicin. Data on fidaxomicin in IBD patients are very limited, mostly from small single-center studies. The aim of this study is to assess long-term outcomes, predictors of efficacy, and safety of fidaxomicin in a large cohort of IBD patients. The primary outcome is the CDI recurrence rate, defined as a positive test result for C. difficile toxin plus treatment with any antimicrobial directed at CDI, within 8 weeks after treatment of an initial episode of CDI. The secondary outcomes include: sustained response rate, escalation of IBD therapy rate, colectomy rate, all-cause mortality. |
| Target group: | All IBD centres who are willing to fill out a REDCap® eCRF for all eligible patients |
| Invitation Letter: |
An audit on fertility and pregnancy after surgery for IBD
| Project leaders: |
Prof. Gianluca Pellino, Dr. Alice Gori, Prof. Matteo Rottoli, Mr. Valerio Celentano, Salvatore Leone , Prof. Antonino Spinelli, Prof. Giuseppe S. Sica, Prof. Gianluca Sampietro, Prof. Francesco Selvaggi |
| Purpose and outcome: |
Colorectal surgery centers from any country with high IBD incidence (>/= 50 patients in the study period) will be eligible for the study. Each center will create a work team composed by: 1 Hospital lead/Principal Investigator, 3 collaborators, 1 data validator. Inclusion criteria
Exclusion criteria
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| Target group: | Participation is open to all IBD centers with a medium-high IBD incidence who has retrospective data of CD patients complicating simplex intra-abdominal abscess and willingness to collect and share it. |
| Invitation Letter: |
Closed research studies
2022
Ustekinumab as a Second-line therapy after Anti-integrin Failure in anti-TNFα naïve patients – real-life international data on safety and Efficacy
| Project leaders: |
João A. Cunha Neves, MD*; Joana Roseira, MD, PhD student*; Helena Tavares de Sousa, MD, PhD student* *Gastroenterology Department – CHUA – Centro Hospitalar Universitário do Algarve, Portimão, Portugal |
| Purpose and outcome: |
Rational: Vedolizumab and ustekinumab are considered the top-tier safest biologic medications for inflammatory bowel disease (IBD). Both these drugs are important therapeutic options in a particular pool of patients not suitable to anti-TNFα drugs, namely those with present or previous malignancies and elderly. Once vedolizumab failure is established, most patients will be offered ustekinumab therapy, and robust evidence on efficacy and safety of this second-line treatment regimen in this setting is lacking. Research hypothesis: Primary objective: To assess clinical remission of ustekinumab as second-line treatment after failure of vedolizumab in anti-TNFα naïve patients. Secondary objectives:1) To assess the durability of ustekinumab as second-line treatment after vedolizumab failure versus after anti-TNFα failure. 2) To assess objective (decrease in biomarker) efficacy of ustekinumab as second-line treatment after failure of vedolizumab in anti-TNFα naïve patients. 3) To assess endoscopic efficacy (response and remission) of ustekinumab as second-line treatment after failure of vedolizumab in anti-TNFα naïve patients. 4) To compare the efficacy of ustekinumab as second-line treatment after vedolizumab failure versus after anti-TNFα failure. 5) To assess the safety profile of ustekinumab either after vedolizumab or after anti-TNFα. |
| Target group: | Every IBD centre with a retrospective database or list of adult IBD patients, with easily retrievable data and a low risk of missed cases, who are willing to provide information about their patients. |
| Results: |
Not-Finalized |
Long-term follow-up of checkpoint inhibitors-induced ileo-colitis
| Project leaders: |
Department of medical sciences, University of Turin, Turin, Italy. Internal medicine, Department of internal medicine, IRCCS San Matteo Hospital Foundation, University of Pavia, Pavia, Italy |
| Purpose and outcome: |
The main objective of this study is the evaluation of the incidence rate of colitis remission basing on the CTCAE scale within 12 months.
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| Target group: |
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| Results: |
Presentation at National Study Group meeting at ECCO’18. Project reviewed by ClinCom. GB approved the promotion of the survey to ECCO Community. Dissemination started in December 2022. Conference Paper, 30° Congresso Nazionale delle Malattie Digestive FISMAD. DOI: 10.1016/S1590-8658(24)00431-6 |
PANDORA: A European study about prevalence, clinical management and outcome of acute pancreatitis in IBD
| Project leaders: |
Pancreas Institute, University of Verona, Italy |
| Purpose and outcome: |
The primary aim of the study is to evaluate the prevalence of AP in IBD patients. Secondary aims include:
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| Target group: | Each IBD center which maintain a prospective or retrospective list of adult IBD patients, with easily retrievability of data and a low risk of missed cases, who are willing to provide information about their patients with one or more pancreatic disorders |
| Results: | Conference paper DDW 2024 – DOI: 10.1016/S0016-5085(24)03053-1 |
Case controlled study of UC patients undergoing surgery after TOFA vs biologics
| Project leaders: |
Careggi University Hospital, Firenze, Italy |
| Purpose and outcome: |
The aim of this study would be to determine the safety of TOFA administration in the weeks before total colectomy for medically refractory UC. In addition, a subsequent analysis on potential predictive factors of adverse outcomes within TOFA group of treatment might provide precious information on safe patient selection. |
| Target group: |
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| Results: | Article published on the American Journal of Gastroenterology, March 19, 2024. DOI: 10.14309/ajg.0000000000002676 |
2020
The Efficacy of Post-Operative Prophylaxis with either vedolizumab or ustekinumab for Crohn's Disease
| Project leaders: |
IBD center at Rabin Medical Center (Petah-Tikva, Israel) |
| Purpose and outcome: | A multicenter retrospective cohort study to assess the efficacy of either vedolizumab or ustekinumab (cases) compared with anti-TNFs (controls) for the prevention of CD recurrence after a curative ileocecal resection. |
| Results: |
Submission of an abstract to ECCO'21 and a full manuscript thereafter |
2019
Prophylactic versus endoscopy-driven treatment of Crohn's postoperative recurrence
| Project leaders: |
IBD unit of the University Hospital Ghent |
| Purpose and outcome: | The aim of this study is to compare the incidence of ePOR at short term in CD patients after ileocecal resection with two different strategies: prophylactic early postoperative initiation of medical treatment (“pro-active approach”) vs. treatment driven by postoperative endoscopic findings (“reactive approach”). |
| Target group: |
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GlobalSurg | CovidSurg Week
| Project leaders: |
NIHR Global Health Research Unit on Global Surgery |
| Purpose and outcome: |
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| Target group: |
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Prior
Safety and efficacy of combining two biological therapies together or a biological therapy with a new small molecule in patients with IBD and other immune mediated inflammatory diseases
| Project leaders: |
Belgian IBD Research and Development group (BIRD) |
| Purpose and outcome: | • To study the efficacy and safety of combining biological treatments together, or with new small molecules in IBD and IMID. • To identify subgroups of patients who may present safety issues either due to the drugs combinations or patient characteristics itself (age, comorbidities, previous medical history etc.) • To study the outcome on extra-intestinal manifestations if any. • To study the effect of the combination treatment on IBD and IMID disease activity. |
| Results: | Submission of an abstract to ECCO'21 and a full manuscript thereafter |
Effectiveness of dose escalation of ustekinumab in Crohn's disease
| Project leaders: |
Sheba Medical Center (Ramat Gan, Israel) |
| Purpose and outcome: | In patients losing response to ustekinumab, possible therapeutic options may include shortening of interval between doses and intravenous reinduction. However, there is very little evidence to support the effectiveness of dose-optimisation strategy to manage primary or secondary non-response to ustekinumab. Thus, we are proposing a wide collaborative retrospective study to evaluate the effectiveness of dose escalation strategy with usekinumab in CD. |
| Results: |
Full manuscript: Effectiveness of ustekinumab dose escalation in Crohn’s disease patients with insufficient response to standard‐dose subcutaneous maintenance therapy. Kopylov U, Hanzel J, Liefferinckx C, De Marco D, Imperatore N, Plevris N, Baston‐Rey I, Harris RJ, Truyens M, Domislovic V, Vavricka S, Biemans V, Myers S, Sebastian S, Ben‐Horin S, González Lama Y, Gilletta C, Shitrit Ariella B-G, Zelinkova Z, Weishof R, Storan D, Zittan E, Farkas K, Molnar T, Franchimont D, Cremer A, Afif W, Castiglione F, Lees C, Barreiro‐de Acosta M, Lobaton T, Doherty G, Krznaric Z, Pierik M, Hoentjen F, Drobne D. AP&T https://doi.org/10.1111/apt.15784 |
Outcome of pregnancies in female IBD patients treated with vedolizumab (CONCEIVE)
| Project leaders: |
University Hospitals of Leuven (Belgium), the Erasmus MC (Rotterdam, The Netherlands), the Shaare Zedek Medical Center (Jerusalem, Israel) |
| Purpose and outcome: | Very few data are available regarding pregnancy outcomes in female patients with IBD treated with vedolizumab. Expanding the existing study initiatives to a European level would certainly provide more data on the safety of vedolizumab in pregnancy and offspring. European research groups and individual IBD centers are invited to collaborate on this topic in a retrospective, multi-center cohort study. |
| Publications: | Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study. Moens A, van der Woude CJ, Julsgaard M, Humblet E, Sheridan J, Baumgart DC, Gilletta De Saint-Joseph C, Nancey S, Rahier JF, Bossuyt P, Cremer A, Dewit S, Eriksson C, Hoentjen F, Krause T, Louis E, Macken E, Milenkovic Z, Nijs J, Posen A, Van Hootegem A, Van Moerkercke W, Vermeire S, Bar-Gil Shitrit A, Ferrante M. Aliment Pharmacol Ther. 2019 Nov 6. doi: 10.1111/apt.15539 |