An observational study in Inflammatory Bowel Diseases, Crohn Disease and Colitis, Ulcerative (UC), sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Assiut University · Observational
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.
1,487 studies on the registry are indexed under Inflammatory Bowel Diseases; 434 are open to participants now.
This study's planned enrollment of 210 is above the median of 146 across 659 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
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Exclusion Criteria:
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.
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).
Time frame: Baseline
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 251 non-industry observational studies under Inflammatory Bowel Diseases, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 148. This study's planned 12 months is below that.
Counting every sponsor, half of 288 studies reached it within 38 months; a quarter within 20 and three quarters within 132.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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