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NCT Number: NCT07162701

Body Composition Assessment and Monitoring in Inflammatory Bowel Disease

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.

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Key information

Conditions

Body Composition Changes Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Unidad de Enfermedad Inflamatoria Intestinal

Barcelona, 08025, Spain

Location status: Recruiting

Location contact

Antonio Giordano, MD, MSc, PhD

CONTACT

[email protected]

0034 932919000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bioimpedance analysis

Diagnostic Test

Patients' body composition will be assessed using bioimpedance analysis (Akern)

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Giordano, MD, MSc, PhD

CONTACT

[email protected]

0034 932919000

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)

Registry information

Official study title

Body Composition Assessment and Monitoring With Bioelectrical Impedance Analysis to Predict Medical Therapy Efficacy in Inflammatory Bowel Disease (the BAMBIE Study)

Acronym: BAMBIE

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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