Body Composition Assessment and Monitoring in Inflammatory Bowel Disease

NCT07162701 | Recruiting

• 1 other identifier: IIBSP-DAM-2024-216
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

malnutrition; IBD; BIA; composition; body; Crohn; colitis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 months

Study Arms (2)

Ulcerative colitis

Pacients with ulcerative colitis

Diagnostic Test: Bioimpedance analysis

Crohn's disease

Patients with Crohn's disease

Diagnostic Test: Bioimpedance analysis

Interventions

Bioimpedance analysis DIAGNOSTIC_TEST

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

Crohn's disease; Ulcerative colitis

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with IBD (Crohn's disease and ulcerative colitis)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU): collaborator

Study Sites (1)

Unidad de Enfermedad Inflamatoria Intestinal

Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

Malnutrition; Colitis

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Antonio Giordano, MD, MSc, PhD

CONTACT

0034 932919000; dr.antoniogiordano@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 9, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)