ClinicalTrials.gg
RecruitingNCT06648551CONUTUpdated Oct 18, 2024

Diagnostic Performance of Controlling Nutritional Status as a Nutritional Screening Tool in Patients With Inflammatory Bowel Disease

An observational study in Inflammatory Bowel Disease 5, sponsored by Hospital General de Mexico. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-18.

Sponsored by Hospital General de Mexico · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Inflammatory Bowel Disease 5
03

In context

Lead sponsor

Hospital General de Mexico is the lead sponsor of 28 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Ulcerative Colitis patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
4 Years
Patient registry
Yes

Interventions

  • Diagnostic testCONUT

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

06

What researchers measure

Primary outcomes

  1. Diagnostic test

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

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Nallely Hernandez Bueno
    Mexico City, Cuauhtemoc 06720, Mexico
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2023 (actual). Primary completion is estimated for Jul 2025, 20 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2024
First posted
Oct 18, 2024
StartActual
Oct 28, 2023
Primary completionEst.
Jul 1, 2025
CompletionEst.
Oct 28, 2027
Last update
Oct 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06648551
Lead sponsor
Hospital General de Mexico
Responsible party
Nallely Bueno Hernández (Medical Sciences Researcher C, Hospital General de Mexico) — Principal investigator
First posted
Oct 18, 2024
Start date
Oct 28, 2023
Primary completion
Jul 1, 2025 (estimated)
Completion
Oct 28, 2027 (estimated)
Last update
Oct 18, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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