Impact of Therapeutic Intervention on Quality of Life in Patients With Ulcerative Colitis

NCT05271773 | Completed DMC

• 1 other identifier: CAVI_CU
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 10

Brief Summary

This study is therefore postulated as a clear alternative that evaluates patients´quality of life, and recognises fecal calprotectin as an inflammatory marker. Longitudinal, prospective, multi-center cohort study to measure the impact that the therapeutic attitude (treatment intensification/de-intensification o escalation/de-escalation) has on the quality of life of patients with UC given a colonoscopy revealing mucosal healing (Mayo 0, Mayo 1); considering as treatment intensification/de-intensification a dose increase or decrease on the same line of treatment, and escalation/de-escalation if there is a change to a new line of treatment.

Conditions

IBD-Inflammatory Bowel Disease; UC - Ulcerative Colitis

Keywords

PRO- patient reported outcomes; HRQOL - health-related quality of life; mucosal healing; ASA - acetylsalicylic acid; CRP - C reactive protein; IBDQ - Inflammatory Bowel Disease Questionnaire; SPSS

Outcome Measures

Primary Outcomes (1)

• To measure the impact that the therapeutic attitude, based on IBDQ9 and IBD control questionaire, has on the quality of life of patients with UC given a colonoscopy revealing mucosal healing

  After 6 and 12 months, to measure the impact that the therapeutic attitude (treatment intensification/de-intensification o escalation/de-escalation) has on the quality of life of patients with UC given a colonoscopy revealing mucosal healing (Mayo 0, Mayo 1); considering as treatment intensification/de-intensification a dose increase or decrease on the same line of treatment, and escalation/de-escalation if there is a change to a new line of treatment.

  at 6 and 12 months

Secondary Outcomes (2)

• To evaluate the impact of inflammatory markers

  at 6 and 12 months

• Outbreak risk assessment depending on the intervention developed

  at 6 and 12 months

Study Arms (2)

Mayo 0

Patients with an established diagnosis of UC through regular criteria (clinical, analytical, endoscopic, radiological and/or histological ones), in clinical remission (partial Mayo score ≤2) for at least three months, who had undergone surveillance colonoscopy after 12 months from the study outset, with a Mayo 0 endoscopic activity.

Mayo 1

Patients with an established diagnosis of UC through regular criteria (clinical, analytical, endoscopic, radiological and/or histological ones), in clinical remission (partial Mayo score ≤2) for at least three months, who had undergone surveillance colonoscopy after 12 months from the study outset, with a Mayo 1 endoscopic activity.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an established diagnosis of UC through regular criteria (clinical, analytical, endoscopic, radiological and/or histological ones), in clinical remission (partial Mayo score ≤2) for at least three months, who had undergone surveillance colonoscopy after 12 months from the study outset, with a Mayo 0 or Mayo 1 endoscopic activity.

You may qualify if:

• UC diagnosed.
• Age ≥ 18.
• Signed and dated informed consent form.
• Have undergone a Mayo 0 or 1 endoscopic score colonoscopy while in clinical remission.

You may not qualify if:

• Incomplete colonoscopy.
• Previous bowel resection.
• Ostomy patient.
• Active infection.
• Pregnancy.
• Lack of patient's informed consent.

Sponsors & Collaborators

• Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa: lead

Study Sites (10)

Hospital Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitari Parc Taulí

Sabadell, Catalonia, 08208, Spain

Location

Hospital de Santa Bárbara de Puertollano

Puertollano, Ciudad Real, 13500, Spain

Location

Hospital Universitario de Cáceres

Cáceres, Extremadura, 10004, Spain

Location

Hospital Universitario de Santiago de Compostela

Santiago de Compostela, Galicia, 15706, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38018, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario. Miguel Servet

Zaragoza, 50009, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool specimen (Fecal calprotectin)

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• GETECCU GETECCU

  Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: November 18, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-12

Locations

ES (10)