Evaluating how treatment affects quality of life in ulcerative colitis patients
Impact of Therapeutic Intervention on Quality of Life in Patients With Ulcerative Colitis Depending on the Mucosal Healing Degree
This study is trying to see how different treatments for ulcerative colitis affect the quality of life for patients who have shown signs of healing after a colonoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 114 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa Academic / other |
| Locations | 10 sites (Santander, Cantabria and 9 other locations) |
| Trial ID | NCT05271773 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of therapeutic interventions on the quality of life of patients with ulcerative colitis (UC) who have undergone colonoscopy revealing mucosal healing. It will follow a longitudinal, prospective, multi-center cohort design, measuring outcomes at 6 and 12 months. The study will consider treatment intensification or de-intensification based on the Mayo endoscopic score and evaluate inflammatory markers such as C-reactive protein and fecal calprotectin. The goal is to provide insights into how different treatment strategies affect patient well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of ulcerative colitis and a Mayo 0 or 1 endoscopic score.
Not a fit: Patients with incomplete colonoscopy, previous bowel resection, ostomy, active infections, pregnancy, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that enhance the quality of life for patients with ulcerative colitis.
How similar studies have performed: While there is limited evidence on the specific impact of therapeutic interventions on quality of life in UC patients, previous studies have indicated the importance of mucosal healing in managing inflammatory bowel disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * UC diagnosed. * Age ≥ 18. * Signed and dated informed consent form. * Have undergone a Mayo 0 or 1 endoscopic score colonoscopy while in clinical remission. Exclusion Criteria: * Incomplete colonoscopy. * Previous bowel resection. * Ostomy patient. * Active infection. * Pregnancy. * Lack of patient's informed consent.
Where this trial is running
Santander, Cantabria and 9 other locations
- Hospital Marqués de Valdecilla — Santander, Cantabria, Spain (Recruiting)
- Hospital Universitari Parc Taulí — Sabadell, Catalunya, Spain (Recruiting)
- Hospital de Santa Bárbara de Puertollano — Puertollano, Ciudad Real, Spain (Recruiting)
- Hospital Universitario de Cáceres — Cáceres, Extremadura, Spain (Recruiting)
- Hospital Universitario de Santiago de Compostela — Santiago de Compostela, Galícia, Spain (Recruiting)
- Hospital Universitario de Canarias — La Laguna, Santa Cruz De Tenerife, Spain (Recruiting)
- Hospital Universitario La Princesa — Madrid, Spain (Recruiting)
- Hospital Universitario Ramón y Cajal — Madrid, Spain (Recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Recruiting)
- Hospital Universitario. Miguel Servet — Zaragoza, Spain (Recruiting)
Study contacts
- Study coordinator: Inmaculada Alonso Abreu
- Email: macuaa@hotmail.com
- Phone: 646555151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.