NCT06648551

Brief Summary

The objective of this observational study is to determine the diagnostic performance of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease. The main questions to be answered are: What is the sensitivity and specificity of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease? The participants will: Undergo body composition analysis and a medical history review to understand the characteristics of their current condition, apply the GLIM criteria, and conduct their nutritional assessment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
18mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Oct 2023Oct 2027

Study Start

First participant enrolled

October 28, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2027

Expected
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

1.7 years

First QC Date

July 8, 2024

Last Update Submit

October 16, 2024

Conditions

Inflammatory Bowel Disease 5

Outcome Measures

Primary Outcomes (1)

  • Diagnostic test

    sensitivity and specificity of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease

    one year

Interventions

CONUTDIAGNOSTIC_TEST

It is a scale that uses albumin, lymphocytes, and cholesterol for the diagnosis of malnutrition

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ulcerative Colitis patients

You may qualify if:

  • Age 18 years and older
  • Gender unspecified
  • Histologically confirmed Ulcerative Colitis
  • Diagnosis confirmed by a specialist physician

You may not qualify if:

  • Patients with any amputation or prosthesis
  • Patients with a pacemaker
  • Patients with any neoplasm
  • Pregnancy or lactation
  • With comorbidities such as diabetes, hypertension, heart failure, thyroid problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nallely Hernandez Bueno

Mexico City, Cuauhtemoc, 06720, Mexico

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Disease 5

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Sciences Researcher C

Study Record Dates

First Submitted

July 8, 2024

First Posted

October 18, 2024

Study Start

October 28, 2023

Primary Completion

July 1, 2025

Study Completion (Estimated)

October 28, 2027

Last Updated

October 18, 2024

Record last verified: 2024-10

Locations

ME(1)