Screening of Nutritional Status and Sarcopenia Among Patients With IBD

Inflammatory Bowel Diseases Clinical Trial

Official title:

Screening of Nutritional Status and Sarcopenia Among Inflammatory Bowel Disease Patients in Assuit University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05877209
• Other study ID #: NRS score in IBD
• Status: Not yet recruiting
• Start date: June 15, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: Noha Askalany, Bachelor
• Phone: 00201050028350
• Email: noha.askalany[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Sarcopenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (14)

Cabre E, Gassull MA. Nutrition in inflammatory bowel disease: impact on disease and therapy. Curr Opin Gastroenterol. 2001 Jul;17(4):342-9. doi: 10.1097/00001574-200107000-00008. — View Citation

Casanova MJ, Chaparro M, Molina B, Merino O, Batanero R, Duenas-Sadornil C, Robledo P, Garcia-Albert AM, Gomez-Sanchez MB, Calvet X, Trallero MDR, Montoro M, Vazquez I, Charro M, Barragan A, Martinez-Cerezo F, Megias-Rangil I, Huguet JM, Marti-Bonmati E, Calvo M, Campdera M, Munoz-Vicente M, Merchante A, Avila AD, Serrano-Aguayo P, De Francisco R, Hervias D, Bujanda L, Rodriguez GE, Castro-Laria L, Barreiro-de Acosta M, Van Domselaar M, Ramirez de la Piscina P, Santos-Fernandez J, Algaba A, Torra S, Pozzati L, Lopez-Serrano P, Arribas MDR, Rincon ML, Pelaez AC, Castro E, Garcia-Herola A, Santander C, Hernandez-Alonso M, Martin-Noguerol E, Gomez-Lozano M, Monedero T, Villoria A, Figuerola A, Castano-Garcia A, Banales JM, Diaz-Hernandez L, Arguelles-Arias F, Lopez-Diaz J, Perez-Martinez I, Garcia-Talavera N, Nuevo-Siguairo OK, Riestra S, Gisbert JP. Prevalence of Malnutrition and Nutritional Characteristics of Patients With Inflammatory Bowel Disease. J Crohns Colitis. 2017 Dec 4;11(12):1430-1439. doi: 10.1093/ecco-jcc/jjx102. — View Citation

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available. — View Citation

Donnellan CF, Yann LH, Lal S. Nutritional management of Crohn's disease. Therap Adv Gastroenterol. 2013 May;6(3):231-42. doi: 10.1177/1756283X13477715. — View Citation

Gerasimidis K, McGrogan P, Edwards CA. The aetiology and impact of malnutrition in paediatric inflammatory bowel disease. J Hum Nutr Diet. 2011 Aug;24(4):313-26. doi: 10.1111/j.1365-277X.2011.01171.x. Epub 2011 May 13. — View Citation

Goh J, O'Morain CA. Review article: nutrition and adult inflammatory bowel disease. Aliment Pharmacol Ther. 2003 Feb;17(3):307-20. doi: 10.1046/j.1365-2036.2003.01482.x. — View Citation

Hanauer SB, Stathopoulos G. Risk-benefit assessment of drugs used in the treatment of inflammatory bowel disease. Drug Saf. 1991 May-Jun;6(3):192-219. doi: 10.2165/00002018-199106030-00005. — View Citation

Hartman C, Eliakim R, Shamir R. Nutritional status and nutritional therapy in inflammatory bowel diseases. World J Gastroenterol. 2009 Jun 7;15(21):2570-8. doi: 10.3748/wjg.15.2570. — View Citation

Hebuterne X, Filippi J, Al-Jaouni R, Schneider S. Nutritional consequences and nutrition therapy in Crohn's disease. Gastroenterol Clin Biol. 2009 Jun;33 Suppl 3:S235-44. doi: 10.1016/S0399-8320(09)73159-8. — View Citation

Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5. — View Citation

Lanfranchi GA, Brignola C, Campieri M, Bazzocchi G, Pasquali R, Bassein L, Labo G. Assessment of nutritional status in Crohn's disease in remission or low activity. Hepatogastroenterology. 1984 Jun;31(3):129-32. — View Citation

Lucendo AJ, De Rezende LC. Importance of nutrition in inflammatory bowel disease. World J Gastroenterol. 2009 May 7;15(17):2081-8. doi: 10.3748/wjg.15.2081. — View Citation

Singleton JW, Law DH, Kelley ML Jr, Mekhjian HS, Sturdevant RA. National Cooperative Crohn's Disease Study: adverse reactions to study drugs. Gastroenterology. 1979 Oct;77(4 Pt 2):870-82. — View Citation

Unal NG, Oruc N, Tomey O, Omer Ozutemiz A. Malnutrition and sarcopenia are prevalent among inflammatory bowel disease patients with clinical remission. Eur J Gastroenterol Hepatol. 2021 Nov 1;33(11):1367-1375. doi: 10.1097/MEG.0000000000002044. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening of malnutrition in patients with IBD using and its relation to severity of the disease.	screening of malnutrition in patients with IBD using Nutritional Risk Screening score	Baseline