Body Composition Assessment and Monitoring in Inflammatory Bowel Disease
Observational · No treatment assigned · 1 site · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Body Composition Changes and Malnutrition. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 64
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 1 more requirement(s). There are also 16 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 48 participants are expected to take part.
- Start date: 2025-07-15.
- Main results expected around 2026-07-15 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Spain.
Main thing being measured
- Phase angle change (24 weeks)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Body Composition Changes; Malnutrition |
| Lead sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Collaborators | Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) |
| Enrollment | 48 (estimated) |
| Start date | 2025-07-15 |
| Primary completion (est.) | 2026-07-15 |
| First posted | 2025-09-09 |
| Last updated | 2025-09-09 |
| Official title | Body Composition Assessment and Monitoring With Bioelectrical Impedance Analysis to Predict Medical Therapy Efficacy in Inflammatory Bowel Disease (the BAMBIE Study) |
| ClinicalTrials.gov ID | NCT07162701 |
Interventions
- Bioimpedance analysis (Diagnostic Test)
Patients' body composition will be assessed using bioimpedance analysis (Akern)
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Unidad de Enfermedad Inflamatoria Intestinal | Barcelona | Spain | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.