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Not Yet Recruiting NCT07888023

Validation and Clinical Impact of GLIM Criteria in Patients With Inflammatory Bowel Disease

Conditions: Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative (UC), Malnutrition

Sex: All
Ages: 18 Years – N/A
Enrollment: 210
Sponsor: Assiut University

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. 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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Source: ClinicalTrials.gov (NCT07888023). StuddyBuddy aggregates publicly available trial information.