Status:
RECRUITING
Body Composition Assessment and Monitoring in Inflammatory Bowel Disease
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborating Sponsors:
Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
Conditions:
Body Composition Changes
Malnutrition
Eligibility:
All Genders
18-64 years
Brief Summary
This is a single-center, prospective observational study aiming to describe changes in body composition (specifically, percentage of lean mass and phase angle) in patients with active inflammatory bow...
Eligibility Criteria
Inclusion
- Any sex.
- Age between 18 and 64 years.
- Patients with a definitive diagnosis (\>3 months) of Crohn's disease or ulcerative colitis, according to European Crohn's and Colitis Organization criteria.
- Moderate-to-severe disease luminal activity, with an indication for biologic or JAKi therapy for the induction of clinical remission.
Exclusion
- Unclassified IBD.
- History of intestinal resection for IBD, with the exception of ileocecal resection.
- Short bowel syndrome.
- Indication for medical treatment due to postsurgical recurrence.
- Active perianal disease.
- Indication for medical treatment due to intestinal stricture.
- Previous participation in a clinical trial involving medication for IBD treatment.
- Engaging in vigorous physical activity (\>6 Metabolic Equivalent of Task, METs) for more than 3 days per week.
- Habitual alcohol consumption (\>1 standard drink unit/day).
- Diabetes mellitus with inadequate glycemic control.
- Chronic use of diuretics.
- Chronic kidney disease on dialysis.
- Presence of dependent edema and/or ascites.
- Cardiac pacemaker bearers.
- Pregnant or lactating women.
- Inability to sign informed consent.
Key Trial Info
Start Date :
July 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 15 2028
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07162701
Start Date
July 15 2025
End Date
July 15 2028
Last Update
September 9 2025
Active Locations (1)
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1
Unidad de Enfermedad Inflamatoria Intestinal
Barcelona, Spain, 08025