Observational study on therapies for Inflammatory Bowel Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of new biological and small molecule therapies in patients with Inflammatory Bowel Disease (IBD), specifically those who have previously failed at least one advanced therapy. The study will include both retrospective and prospective cohorts, with participants recruited from the Lazio Regional Health System over a 24-month period. Eligible patients will be those aged 18 to 70 with a diagnosis of Crohn's Disease (CD) or Ulcerative Colitis (UC) who have started a new therapy within the last 8 weeks. Participants will provide informed consent and will be monitored for treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 to 70 years
2. Patients with a previous diagnosis of CD or UC at least 3 months before baseline.
3. Patients who have already failed at least one advanced (biological or small molecule) therapy for IBD and who have experienced failure to at least one mechanism of action (failure is defined as primary failure, secondary failure, or intolerance).
4. Patients who have already started a new advanced therapy for IBD based on clinical practice indication (primary loss of response, secondary loss of response, intolerance to the previous drug) since at least 1 week and up to 8 weeks after starting it.
5. Written informed consent certifying the willingness of the subject to participate to the study.

Exclusion Criteria:

1. Age \< 18 years.
2. Patients with diagnosis of indeterminate colitis.
3. Patients naive to advanced (biological or small molecule) therapy for IBD.
4. Refusal to sign written informed consent certifying the willingness of the subject to participate to the study.

Where it's running

• Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD
  Roma, Italy Recruiting

Study contacts

• Principal investigator: Franco Scaldaferri — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Franco Scaldaferri, PI
• Email: franco.scaldaferri@policlinicogemelli.it
• Phone: +390630156876

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Maternal and infant microbiome links to infant gut inflammation and pregnancy outcomes in people with IBD

  This project will see if mothers' microbiomes, diets, and breastmilk are linked to infant gut inflammation (measured by fecal calprotectin) in pregnant people with and without IBD.

  Recruiting University of British Columbia · Vancouver, British Columbia and 1 other locations · NCT07385807

• Infliximab plus the Crohn's Disease Exclusion Diet for children with Crohn's disease

  This will test whether starting a Crohn's Disease Exclusion Diet at the same time as infliximab helps children with moderate-to-severe Crohn's disease get better and stay in remission.

  Recruiting University of British Columbia · Vancouver, British Columbia · NCT07314606

• SMART-IBD app for teens with inflammatory bowel disease

  This will test whether the SMART-IBD smartphone app helps adolescents ages 13–17 with IBD take their medicines and manage symptoms better than completing daily diaries alone.

  Recruiting Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT07195123

• Melatonin to improve sleep quality in adults with inflammatory bowel disease in remission

  This study tests whether melatonin can improve sleep quality in adults with IBD who are in clinical remission.

  Recruiting Phase 4 Mahidol University · Bangkok Noi, Bangkok · NCT07737665

• Individualizing Anti-TNF Therapy in IBD

  This study tests whether genetic markers can predict which anti-TNF–naïve IBD patients will respond to their first anti-TNF treatment.

  Recruiting Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT07644117

• BDHK-2009 safety test in healthy adults

  This early-stage test checks if BDHK-2009 tablets are safe and tolerable in healthy adults aged 18–55 compared with placebo.

  Recruiting Phase 1 Benethera (Shaoxing) Biotechnology Co., Ltd. · Hangzhou, Zhejiang · NCT07632573

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.