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)

Call for study proposals

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

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.

Secondary objectives of the study are:
1. to evaluate the clinical remission with specific colitis CTCAE scale and with the Physician Global Assessment (PGA)
2. to assess endoscopic and histological healing, whether the endoscopic examination is repeated after the diagnosis.
3. to evaluate the fatality rate and the causes of death among these patients; these will be calculated by gathering information on the modality of death during the follow-up period.
4. to identify all the different patterns of this kind of enterocolitis, by collecting data on the localisation (colonic, ileal, ileo-colonic), the endoscopic (ulcerative, oedematous) and histological features (granulomatosis, crypt abscesses, etc.), and their related prognosis.
5. to describe any epidemiological features of CIC such as male/female ratio, mean age, smoking habits, previous oncological treatments, tumour localisation and will assess any predictors of colitis development or clinical response to colitis-related treatment.

Deadline to participate: October 31, 2022
Target group:

  • Any IBD, gastroenterological, oncological, or internal medicine center dealing with ICIC that are willing to provide data with an (expected) date of delivery of 31st December 2022 for the retrospective part and to enroll prospectively patients from January 2023 to December 2023 and follow them up for 12 months (prospective part)
  • All centers that are willing to ask for approval to their local ethics committee, according to their local jurisdiction; each center will be responsible for the submission to the local ethics committee
Link to the invitation letter Invitation Letter
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:

  • To investigate the aetiology of AP in IBD patients
  • To investigate the relationship between IBD medications and AP
  • To investigate the relationship between IBD medications and CPEE
  • To define the role of different imaging modalities in improving diagnosis of pancreatic abnormalities
  • The explore the clinical outcome of specific pancreatic manifestations
Deadline to participate: September 14, 2022
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
Link to the invitation letter Invitation Letter

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.

Deadline to participate: September 15, 2022
Target group:
  • IBD centres with the possibility to retrieve data on UC patients undergoing colectomy and the necessary information in the perioperative period
  • IBD centres who are willing to fill out an electronic clinical research form (eCRF) through REDCap® software for all included patients.
  • IBD centres who are willing to verify themselves if approval by their local ethical committee and informed consent of the patient is mandatory in their jurisdiction for a retrospective non interventional study. If so, the IBD centre will be responsible for the submission to the local ethical committee as well as collection of the informed consent
Link to the invitation letter Invitation Letter

Closed research studies

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”).
Deadline to participate: June 30, 2021
Target group:
  • IBD centres which kept track of Crohn’s patients that underwent ileocecal resection over at least the past decade
  • IBD centers who are willing to fill out completely and correctly an electronic clinical research form (eCRF) through REDCap® software for all included patients
  • IBD centers who are willing to verify themselves if approval by their local ethical committee and informed consent of the patient is mandatory in their jurisdiction for a retrospective non interventional study. If so, the IBD center will be responsible for the submission to the local ethical committee as well as collection of the informed consent. As mentioned, the study was already approved by the Ethical Committee of University Hospital Ghent (Belgium) on 05/03/2021
  • IBD centres who are willing to do everything to avoid missing data as much as possible by contacting patients, colleague gastroenterologists, general practitioners and any other physicians in charge of the patient

GlobalSurg | CovidSurg Week 
Project leaders:
NIHR Global Health Research Unit on Global Surgery
Purpose and outcome:
  • To determine the optimal timing of surgery following SARS-CoV-2 infection;
  • Determine assess key global surgical indicators, such as postoperative mortality.
Deadline to participate: October 2020
Target group:
  • In order to achieve the above aims, this study will include all patients undergoing surgery
    with a preoperative, postoperative or no SARS-CoV-2 infection.
  • All hospitals are eligible
    to participate, regardless having admitted SARS-CoV-2 infected patients or not.

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
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.


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

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


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