Screening of Nutritional Status and Sarcopenia Among Patients With IBD

NCT ID: NCT05877209

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2023-12-01

Brief Summary

1. Screening of malnutrition in patients with IBD and its relation to severity of the disease.

2. Determination of severity of malnutrition in IBD patients.

3. Assessment of Sarcopenia in patients with IBD.

Detailed Description

Inflammatory bowel disease (IBD) encompasses Crohn's disease (CD) and ulcerative colitis (UC) is a chronic, relapsing, inflammatory disorder of the digestive tract that characteristically develops in adolescence and early adulthood. IBD is associated with inflammation and negative nutrient balance, which is a risk factor for malnutrition. Multiple definitions of malnutrition have been proposed in literature. The early definitions of malnutrition referred to a state of under nutrition. Subsequently, an imbalance of nutrients, either deficiency or excess, was included in the definition. World Health Organization (WHO) defines malnutrition as deficiency, excess, or imbalance in a person's intake of energy and/or nutrients. The reported prevalence of malnutrition in IBD varies between 16 % and 75%. Several studies have reported a prevalence of weight loss in 70%-80% of hospitalized IBD patients and in 20%-40% of outpatients with CD. Several factors contribute to malnutrition in IBD patients. It is known that a reduced oral food intake is a main determinant of malnutrition in patients with IBD. Several mechanisms are involved in the reduction of food intake. Patients with active IBD often experience loss of appetite due to nausea, vomiting, abdominal pain, and diarrhea. Medications may also induce nausea, vomiting, or anorexia. Glucocorticoids often reduce phosphorus, zinc, and calcium absorption and may lead to osteoporosis. Long-term sulfasalazine therapy, a folic acid antagonist, might be related to anemia. Hospitalization itself or prolonged restrictive diet may lead to a significant reduction of food intake. The severity of malnutrition in IBD patients is dependent on the activity, duration and extent of the disease. In particular, on the magnitude of the inflammatory systemic response mediated by pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF) and interleukins-1 and -6, which can increase catabolism and lead to anorexia. Sarcopenia has been defined by the European Working Group on Sarcopenia (EWGSOP) combining low muscle strength, low muscle quantity/quality, and low physical performance. There has been a major change from the original operational definition, as low muscle strength was added as a prerequisite to definitions based only on the detection of low muscle mass. In addition, low physical performance is considered a predictor for poor outcomes; thus, such measures are useful to classify the severity of sarcopenia. Nutritional status is traditionally measured with anthropometric tests including height, weight, body mass index (BMI), body circumferences (waist, hip, and limbs), and skinfold thickness. These parameters improve with IBD treatment but may not reflect changes in body composition. The purpose of the NRS-2002 system is to detect the presence of under nutrition and the risk of developing under nutrition in the hospital setting. It contains the nutritional components of Malnutrition Universal Screening Test (MUST). In addition, a grading of severity of disease as a reflection of increased nutritional requirements. With the prototypes for severity of disease given, it is meant to cover all possible patient categories in a hospital.

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Patients above the age of 18 years old and diagnosed to have IBD (UC or CD). The diagnosis of IBD will be based on clinical, laboratory, radiological, endoscopic and/or histopathological data.
• Naïve IBD patients or those currently on treatment

Exclusion Criteria

• Patients undergoing intentional weight loss plan.
• Patients with Cardiac Diseases.
• Patients with Liver diseases
• Patients with Thyroid active diseases.
• Pregnant women with IBD.
• Diabetic patients.
• Patients with extra-intestinal malignancies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Noha Ahmed Mohamed Refaat Askalany

Doctor / Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherif Kamel, professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Noha Askalany, Bachelor

Role: CONTACT

noha.askalany@yahoo.com

00201050028350

Sherif Kamel, professor

Role: CONTACT

shereek_kamel@aun.edu.eg

00201222303690

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Other Identifiers

NRS score in IBD

Identifier Type: -

Identifier Source: org_study_id