Body Composition Assessment and Monitoring in Inflammator... | NCT07162701

Studies
Body Composition Assessment and Monitoring in Inflammatory Bowel Disease

NCT07162701

Sponsor

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

Status

Recruiting

Last Update Posted

Sep 9, 2025Actual

Enrollment

48Estimated

Phase

Not provided

Conditions

Body Composition Changes
Malnutrition

Interventions

Bioimpedance analysis

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2025Actual

Primary Completion Date

Jul 15, 2026Estimated

Completion Date

Jul 15, 2028Estimated

First Submitted Date

Aug 6, 2025

First Submission Date that Met QC Criteria

Sep 8, 2025

First Posted Date

Sep 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2025

Last Update Posted Date

Sep 9, 2025Actual

Name	Class
Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ulcerative colitis		Pacients with ulcerative colitis	Diagnostic Test: Bioimpedance analysis
Crohn's disease		Patients with Crohn's disease	Diagnostic Test: Bioimpedance analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bioimpedance analysis	Diagnostic Test	Patients' body composition will be assessed using bioimpedance analysis (Akern)	Crohn's disease Ulcerative colitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antonio Giordano, MD, MSc, PhD	Contact	0034 932919000		dr.antoniogiordano@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unidad de Enfermedad Inflamatoria Intestinal	Recruiting	Barcelona		08025	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Due to local privacy regulations, data can only be shared upon written, motivated request and approval by the local IEC.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition
D003092	Colitis

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided