Body composition monitoring for people with IBD starting biologic or JAK inhibitor therapy
Body Composition Assessment and Monitoring With Bioelectrical Impedance Analysis to Predict Medical Therapy Efficacy in Inflammatory Bowel Disease (the BAMBIE Study)
This project will use bioelectrical impedance to track lean mass percentage and phase angle over one year in adults with moderate-to-severe Crohn's disease or ulcerative colitis who are starting biologic or JAK inhibitor treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT07162701 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective observational study that follows adults with confirmed Crohn's disease or ulcerative colitis who begin biologic or JAK inhibitor therapy. Body composition will be measured by bioelectrical impedance analysis at baseline, 24 weeks, and 52 weeks after treatment start. Clinical activity scores, endoscopic findings, and laboratory data will be collected when available alongside the BIA measurements. All treatments follow routine clinical care and the study does not change prescribed therapy.
Who should consider this trial
Good fit: Adults aged 18–64 with a confirmed diagnosis of Crohn's disease or ulcerative colitis of more than three months' duration who have moderate-to-severe luminal activity and are about to start biologic or JAK inhibitor therapy, and who meet safety-related exclusions.
Not a fit: Patients with short bowel syndrome, major prior intestinal resections (other than ileocecal resection), active perianal disease, stricturing complications, uncontrolled diabetes, or who are not starting biologic/JAK inhibitor treatment are unlikely to benefit from this monitoring approach in the study context.
Why it matters
Potential benefit: If successful, the project could help clinicians detect and track muscle loss or malnutrition earlier and support better nutritional and treatment decisions for people with IBD.
How similar studies have performed: Previous observational work using bioelectrical impedance and phase angle in IBD and other chronic illnesses has shown correlations with nutritional status and outcomes, but prospective data specifically around body composition changes after starting biologics or JAK inhibitors are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Barcelona
- Unidad de Enfermedad Inflamatoria Intestinal — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Antonio Giordano, MD, MSc, PhD
- Email: dr.antoniogiordano@gmail.com
- Phone: 0034 932919000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.