NCT07162701Recruiting
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)
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 48 (estimated)
- First submitted
- 6 Aug 2025
- Start date
- 15 Jul 2025
- Primary completion date
- 15 Jul 2026
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Diseases
- Crohn's disease
- NCT number
- NCT07162701
What you commit to
- Study type: Observational
- Planned participants: 48
- From 15 Jul 2025 to the primary completion date, 15 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in a clinical trial involving medication for IBD treatment.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unidad de Enfermedad Inflamatoria Intestinal Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.