Body Composition Assessment and Monitoring in Inflammatory Bowel Disease (BAMBIE)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Enrolling

Conditions

Malnutrition

Body Composition Changes

Treatments

Diagnostic Test: Bioimpedance analysis

Study type

Observational

Funder types

Other

Identifiers

NCT07162701

IIBSP-DAM-2024-216

Details and patient eligibility

About

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 bowel disease (IBD), including ulcerative colitis and Crohn's disease.

The study will recruit patients with a confirmed IBD diagnosis who are starting biologic therapy or Janus kinase inhibitors (JAKi) to induce clinical remission. Body composition will be assessed using bioelectrical impedance analysis (BIA) at baseline (time 0), 24 weeks, and 52 weeks after starting medication. Clinical disease activity, endoscopic findings, and laboratory data will also be collected at various time points if available.

The study has a total duration of 36 months, including a 12-18 month patient inclusion period and a 12-month follow-up. Patients will provide informed consent, and all treatment decisions will follow standard clinical practice, as this is a non-interventional observational study.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.