Body composition monitoring for people with IBD starting biologic or JAK inhibitor therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.