Body Composition Assessment and Monitoring in Inflammatory Bowel Disease
Key facts
- Where
- Barcelona, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT07162701, who can take part
Where in Spain
- Unidad de Enfermedad Inflamatoria IntestinalBarcelona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Trial code
- NCT07162701
- Record updated
- 9 September 2025
- Original description
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.Read full original descriptionShow less
Body Composition Assessment and Monitoring With Bioelectrical Impedance Analysis to Predict Medical Therapy Efficacy in Inflammatory Bowel Disease (the BAMBIE Study)
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.
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: Previous participation in a clinical trial involving medication for IBD treatment; History of intestinal resection for IBD, with the exception of ileocecal resection; Short bowel syndrome; Active perianal disease; Diabetes mellitus with inadequate glycemic control; Chronic kidney disease on dialysis; Cardiac pacemaker bearers; Unclassified IBD; Indication for medical treatment due to postsurgical recurrence; Indication for medical treatment due to intestinal stricture; 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); Chronic use of diuretics; Presence of dependent edema and/or ascites; Pregnant or lactating women; Inability to sign informed consent.