Inflammatory Bowel DiseasesNCT07888023
Validation and Clinical Impact of GLIM Criteria in Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Assiut University.
Trial summary
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic inflammatory conditions of the digestive tract that frequently lead to malnutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative (UC)
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients diagnosed with Inflammatory Bowel Disease (Crohn's disease or Ulcerative Colitis) based on established clinical, endoscopic, and histopathological criteria, presenting to the outpatient clinics or admitted to the inpatient wards of the Department of Tropical Medicine and Gastroenterology at Al-Rajhi Liver Hospital, Assiut University, Egypt.
Who may be able to join
- Confirmed diagnosis of Inflammatory Bowel Disease (Crohn's disease or Ulcerative Colitis) based on clinical, endoscopic, and histopathological criteria.
- Adult patients aged 18 years or older.
- Patients managed at the inpatient wards or outpatient clinics of Tropical Medicine and Gastroenterology at Al-Rajhi Liver Hospital.
- Ability and willingness to provide written informed consent.
Who cannot join
- Pregnancy.
- Inability to understand the study protocol or provide informed consent.
- Active malignancy likely to independently affect nutritional status.
- Severe organ failure or another major systemic disease expected to independently determine nutritional status.
- Marked edema, ascites, or any condition making body weight or body-composition interpretation unreliable.
- Recent major surgery with acute postoperative nutritional changes.
About this study
Official title: Validation and Clinical Impact of the Global Leadership Initiative on Malnutrition Criteria in Patients With Inflammatory Bowel Diseases
Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic inflammatory conditions of the digestive tract that frequently lead to malnutrition. Malnutrition in individuals with IBD is associated with diminished quality of life, impaired treatment response, and higher rates of hospital admission. To standardize nutritional diagnosis, the Global Leadership Initiative on Malnutrition (GLIM) introduced a consensus framework combining phenotypic criteria (weight loss, low body mass index, and reduced muscle mass) and etiologic criteria (reduced food intake/assimilation and disease-related inflammation).
The primary objective of this prospective observational study is to validate the diagnostic accuracy and sensitivity of the GLIM criteria in identifying malnutrition among hospitalized and ambulatory adult patients with IBD, using the Subjective Global Assessment (SGA) as the reference standard. Secondary objectives include determining the prevalence and severity of GLIM-defined malnutrition, evaluating its relationship with clinical, functional, and inflammatory parameters, and identifying clinical predictors of malnutrition in this population.
Adult participants diagnosed with IBD presenting to the inpatient wards or outpatient clinics of Al-Rajhi Liver Hospital (Assiut University) will be enrolled. Participants will undergo initial nutritional risk screening using the Malnutrition Universal Screening Tool (MUST) for outpatients or the Nutritional Risk Screening 2002 (NRS-2002) for inpatients. Full nutritional assessment will be conducted via GLIM criteria and SGA. Additional evaluations will include anthropometric measurements (mid-arm muscle circumference and calf circumference), muscle strength testing via handgrip dynamometry, dietary intake assessment, routine laboratory panels (complete blood count, inflammatory markers, liver function tests, electrolytes, and fecal calprotectin), and endoscopic disease activity scores (SES-CD or Mayo endoscopic score) when clinically available.
- Keywords
- GLIM criteria, Subjective Global Assessment, Nutritional Assessment, Malnutrition Screening
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Inflammatory Bowel Disease (IBD) | Adult patients diagnosed with Inflammatory Bowel Disease (Crohn's disease or Ulcerative Colitis) evaluated at the inpatient wards and outpatient clinics of Al-Rajhi Liver Hospital. All enrolled participants undergo initial nutritional risk screening using MUST (for outpatients) or NRS-2002 (for inpatients), followed by comprehensive nutritional assessment according to the Global Leadership Initiative on Malnutrition (GLIM) criteria and Subjective Global Assessment (SGA). Assessments include detailed dietary history, anthropometry (mid-arm muscle circumference, calf circumference), muscle strength via handgrip dynamometry, and laboratory markers (complete blood count, liver functions, CRP, ESR, fecal calprotectin, electrolytes). Endoscopic disease activity is recorded using the Simple Endoscopic Score for Crohn's Disease (SES-CD) or the Mayo endoscopic score for Ulcerative Colitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy and Sensitivity of the Global Leadership Initiative on Malnutrition (GLIM) Criteria
Diagnostic performance of the GLIM criteria will be evaluated by calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic agreement (Cohen's kappa) against the Subjective Global Assessment (SGA) as the reference standard. A GLIM diagnosis of malnutrition requires at least one phenotypic criterion (unintentional weight loss, low body mass index, or reduced muscle mass) combined with at least one etiologic criterion (reduced food intake/assimilation or systemic inflammation/disease burden).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolles Elkess Isaac Soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888023
- Sponsor's protocol ID
- GLIM Criteria for IBD Patients
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No