Body Composition Assessment and Monitoring in Inflammatory Bowel Disease

Body Composition Assessment and Monitoring With Bioelectrical Impedance Analysis to Predict Medical Therapy Efficacy in Inflammatory Bowel Disease (the BAMBIE Study)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07162701

Acronym

BAMBIE

Enrollment

Registered

2025-09-09

Start date

2025-07-15

Completion date

2028-07-15

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Composition Changes, Malnutrition

Keywords

malnutrition, IBD, BIA, composition, body, Crohn, colitis

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 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.

Interventions

DIAGNOSTIC_TESTBioimpedance analysis

Patients' body composition will be assessed using bioimpedance analysis (Akern)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Phase angle change	24 weeks	To describe the changes in Phase angle observed between week 0 (baseline) and week 24 after the commencement of biologic or JAK inhibitor therapy.
Body Composition change	24 months	To describe the changes in Lean Mass index observed between week 0 (baseline) and week 24 after the commencement of biologic or JAK inhibitor therapy.

Countries

Spain

Contacts

Primary ContactAntonio Giordano, MD, MSc, PhD

dr.antoniogiordano@gmail.com0034 932919000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026