Body Composition ChangesBAMBIENCT07162701
Body Composition Assessment and Monitoring in Inflammatory Bowel Disease
An observational study of Body Composition Changes and Malnutrition, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Body Composition Changes, Malnutrition
- What is being tested?
- Bioimpedance analysis
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2025to 15 Jul 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with IBD (Crohn's disease and ulcerative colitis)
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Unidad de Enfermedad Inflamatoria Intestinal
Barcelona, 08025
Antonio Giordano, MD, MSc, PhD, 0034 932919000, dr.antoniogiordano@gmail.com
About this study
Official title: 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.
- Conditions
- Body Composition Changes, Malnutrition
- Being tested
- Bioimpedance analysis
- Keywords
- malnutrition, IBD, BIA, composition, body, Crohn, colitis
- Medical subject headings
- Malnutrition, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedance analysisDiagnostic test
Patients' body composition will be assessed using bioimpedance analysis (Akern)
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis | Pacients with ulcerative colitis Receives: Diagnostic Test: Bioimpedance analysis | |
| Crohn's disease | Patients with Crohn's disease Receives: Diagnostic Test: Bioimpedance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase angle change
To describe the changes in Phase angle observed between week 0 (baseline) and week 24 after the commencement of biologic or JAK inhibitor therapy.
Measured: 24 weeks
Body Composition change
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start15 Jul 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Composition ChangesStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162701
- Sponsor's protocol ID
- IIBSP-DAM-2024-216
- Acronym
- BAMBIE
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to local privacy regulations, data can only be shared upon written, motivated request and approval by the local IEC.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- BAMBIE / IIBSP-DAM-2024-216
- Conditions
- Body Composition Changes, Malnutrition
- Keywords
- malnutrition, IBD, BIA, composition, body, Crohn, colitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis | – | Diagnostic Test: Bioimpedance analysisPacients with ulcerative colitis |
| Crohn's disease | – | Diagnostic Test: Bioimpedance analysisPatients with Crohn's disease |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with IBD (Crohn's disease and ulcerative colitis)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioimpedance analysisPatients' body composition will be assessed using bioimpedance analysis (Akern) | Diagnostic test | Crohn's disease, Ulcerative colitis |
Primary outcome
Phase angle change
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No. Due to local privacy regulations, data can only be shared upon written, motivated request and approval by the local IEC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Composition Changes and Malnutrition, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Giordano, MD, MSc, PhD (0034 932919000, dr.antoniogiordano@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase angle change (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.