National Study Group Projects

IBD National Study Group meeting at the ECCO Congress

IBD National Study Groups often come up with solid clinical research questions but face problems with recruiting a sufficient number of patients. The Clinical Research Committee of ECCO (ClinCom) organises a yearly meeting at the ECCO Congress for representatives of European IBD National Study Groups to:

exchange views on study projects
support the collaboration among study groups
give investigators the opportunity to present their study projects in person

Call for the Study Group Projects

The call for Study Projects 2026 is now open. Please see all the relevant information below.

Submission deadline

October 15, 2025

Read the full call

Template First stage - Study synopsis

Template Second stage - Full Proposal

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)

Review of study protocol: A two-stage process

The assessment of a clinical research protocol consists in a two-stage process.

First Stage: The applicants are called upon to provide a study synopsis. After a careful review, ClinCom will select the projects to be presented at the National Study Group Meeting.

Second Stage: After the meeting, the PI is invited to submit a full protocol taking into account the feedback given during the IBD National Study Group meeting. The protocol, now at its second stage, is reviewed by ClinCom and the ECCO Gorverning Board. Once approved, ECCO supports the dissemination with a call to participate to the study project and to recruit centres within the IBD Community.

Please note: 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 (ecco@ecco-ibd.eu)

Open Study Group Projects

Bone mineral density and risk of osteoporosis in patients with inflammatory bowel disease

Project Leaders: Alicja Ratajczak-Pawłowska, PhD, Prof. Iwona Krela-Kaźmierczak

Deadline to participate: May 30, 2026

Purpose and Outcomes:

This study aims to improve our knowledge on the frequency and consequences of low BMD in IBD and may allow for the development of new criteria for screening for low BMD in patients with IBD.

Target Group:

All IBD centres, who has retrospective data of IBD patients referring to bone mineral density and clinical data (according to study protocol)

Study population:

Minimum number of the patients: 384 patients with IBD (CD or UC diagnosis according to ECCO criteria)
Adult patients followed up in referral centres either as outpatients or as hospitalized patients
Aim to register: 1000 patients

Invitation Letter

International, Multi-centre, Retrospective Cohort Study on Morbidity, Frequency Rates and Timings of Surgical Interventions for Ulcerative Colitis

Project Leaders: Mr. Orestis Argyriou (Research fellow), Dr. Itai Ghersin (Research fellow), Mr. Guy Worley (Consultant colorectal surgeon), Mr. Kapil Sahnan (Consultant colorectal surgeon), Professor Ailsa Hart (Consultant gastroenterologist)

Deadline to participate: October 11, 2024

Purpose and Outcomes: This study intends to serve as a snapshot of the current practices in surgery for ulcerative colitis (UC) in Europe, by hollistically assessing patients´ surgical journey, starting from the index subtotal celectomy.
The Main aims of the study are to

Document morbidities and complications of procedures in UC in a large sample size
Describe and understand variations in practice, particularly regarding reconstructions:
- Choice of recontractive technique
- Stages used in IPAA surgery
- Timings between stages in IPAA surgery
- Surgical techniques

To achieve the above, the main outcome parameters that will be assessed, are:

Morbidity after total/subtotal colectomy
Morbidity after any type of restorative surgery/stages
Percentage of patients that proceed with restorative surgery after colectomy (and which type)
Percentage of IPAA surgery performed in 1, 2 or 3 stages
Percentage of patients, following restorative surgery, that proceed with revisional surgery, excision or diversion, with respective morbidities

Target Group:

Collaborators/Centre inclusion Criteria:

Any European or UK hospital performing surgery for patients with UC (irrespective of volume)

Patient inclusion criteria:

Age >18 years old
Diagnosis of UC
Index colectomy for UC

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

Deadline to participate: October 11, 2024

Purpose and Outcomes

Purpose: study the course of steroid-responsive ASUC patients,

stratified by the type of medical therapy offered (advanced therapy vs 5 ASA/IMM).

Primary outcome: Time until disease relapse/complication after ASUC episode.
Secondary outcomes: Time until therapy escalation; Time until need for steroids; Time until hospitalization due to UC; Time until colectomy; Percentage of semesters with inactive disease.

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

Deadline to Participate: October 11, 2024

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

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 student; Gabriele Dragoni, MD, PhD; Jurij Hanžel, MD, PhD; Triana Lobaton, MD, PhD

Deadline to Participate: October 11, 2024

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

Target group:

All IBD centres which kept track of all medical treatment of patients with ulcerative colitis
All IBD centres who are willing to fill out a complete REDCap® eCRF for all eligible patients, by doing everything to avoid missing data

All IBD centres who are willing to ask for approval to the local Ethics Committees according to the local jurisdiction

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; Péter Bacsur, MD, PhD Student

Deadline to participate: October 11, 2024

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

Invitation Letter

Feasibility and safety of endoscopic submucosal dissection in inflammatory bowel disease: a multicenter European retrospective analysis (ESDEUR-IBD)

Project leaders: María José García, MD; Miguel Fraile, PhD

Deadline to participate: October 11, 2024

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:

To evaluate en-bloc resection rate (technical success) and colectomy due to ESD failure (clinical success) in IBD patients.

Secondary outcomes:

To describe the immediate and delayed complications of ESD
To assess the local recurrence of ESD
To identify predictive factors for colectomy due to ESD failure
To investigate the presence of synchronous and metachronous lesions during surveillance colonoscopies
To assess the risk of IBD relapse following ESD

Target group:

Target group:

IBD centres who have performed ESD in IBD patients
IBD centres who are willing to fill out an electronic clinical research form (eCRF) through REDCap® software

Inclusion criteria:

Patients older than 18 years who underwent ESD at least one month before the date of inclusion. All ESD procedures since 2004 could be included, when this technique was described for colonic lesions.
Ulcerative colitis, Crohn’s disease, or unclassified IBD diagnosed at least 3 months before ESD.

Exclusion criteria:

Pregnancy
Invisible dysplasia at the time of ESD
Total colectomy before ESD procedure

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 Truyens, Prof. Dr. Triana Lobatón

Deadline to participate: October 11, 2024

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.

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 leader(s): Mariam Ali

Deadline to participate: October 11, 2024

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.

Target group: Survey: IBD Gastroenterologists from European IBD centres

Invitation Letter

An audit on fertility and pregnancy after surgery for IBD

Project Leader(s): 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

Deadline to participate: Please refer to the Invitation Letter

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

All female patients who underwent surgery for CD or UC before the age of 36 (at the time of the study) from 2000 to 2022.
Diagnosis of Crohn's disease or ulcerative colitis
Ability to understand the study
For the non-surgical group, all patients who received treatment for CD or UC from 2000 to 2022 will be considered

Exclusion criteria

˂ 18 years of age at the time of the study

Lack of diagnostic certainty of Crohn's disease or ulcerative colitis

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 Study Group Projects

Fidaxomicin for Clostridium difficile Infection in IBD: a multicenter retrospective cohort study

Project Leader(s): Prof. Flavio Caprioli, Dr. Daniele Noviello

Results: Article pubished on JCC, Volume 19, Issue 5, May 2025

https://academic.oup.com/ecco-jcc/advance-article/doi/10.1093/ecco-jcc/jjaf056/8102790

https://doi.org/10.1093/ecco-jcc/jjaf056

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.

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

Results: NA

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:
1) Efficacy of ustekinumab will be less impacted by vedolizumab exposure compared to anti-TNFα exposure.
2) Safety profiles will be similar between ustekinumab after vedolizumab and ustekinumab after anti-TNFα.

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.

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

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

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.

PANDORA: A European study about prevalence, clinical management and outcome of acute pancreatitis in IBD

Project leaders: Pancreas Institute, University of Verona, Italy

Results: Conference paper DDW 2024 – DOI: 10.1016/S0016-5085(24)03053-1

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

Case controlled study of UC patients undergoing surgery after TOFA vs biologics

Project leaders: Careggi University Hospital, Firenze, Italy

Results: Article published on the American Journal of Gastroenterology, March 19, 2024. DOI: 10.14309/ajg.0000000000002676

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.

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)

Results: Submission of an abstract to ECCO'21 and a full manuscript thereafter

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.

Prophylactic versus endoscopy-driven treatment of Crohn's postoperative recurrence

Project leaders: IBD unit of the University Hospital Ghent

Results: NA

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”).

GlobalSurg | CovidSurg Week

Project leaders: NIHR Global Health Research Unit on Global Surgery

Results: -

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.

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.

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)

Results: Submission of an abstract to ECCO'21 and a full manuscript thereafter

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.

Effectiveness of dose escalation of ustekinumab in Crohn's disease

Project leaders: Sheba Medical Center (Ramat Gan, Israel)

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

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.

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)

Results: Full Manuscript:

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

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.