Malnutrition in Chronic Gastrointestinal Diseases Cross-sectional Study

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University Medicine Greifswald

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Updated on 19 February 2024

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ct scan

computed tomography

MRI

endoscopic ultrasound

cirrhosis

gastroscopy

gastrointestinal disorders

malnutrition

liver cirrhosis

hepatocellular carcinoma

body measurements

gastrointestinal disease

short bowel

pancreatitis

gastritis

muscle wasting

chronic diseases

short bowel syndrome

bowel resection

cysts

pancreatic resection

pancreaticojejunostomy

mrcp

magnetic resonance cholangiopancreatography

Summary

Malnutrition and muscle wasting are common consequences of life-threatening, chronic diseases of the gastrointestinal tract. Such diseases include liver cirrhosis, chronic pancreatitis and short bowel syndrome. Malnutrition and muscle wasting increase the risk of complications, reduce the life expectancy and impair the quality of life. The development of malnutrition and muscle wasting is different, as is the diagnosis and nutritional treatment. There are also different mechanisms of origin for the underlying diseases. The aim of the study is to compare data related to nutrition and physical condition of patients with liver cirrhosis, chronic pancreatitis and short bowel syndrome. Malnutrition and muscle wasting within the specific diseases will be characterized and possible correlations will be identified.

For this, malnourished and non-malnourished patients of the different diseases are compared with controls patients with non-specific complaints of the gastrointestinal tract as well as with healthy study participants.

Data on food intake, physical activity, body composition and body measurements as well as muscle strength and muscle function are recorded. Blood values as well as transport and barrier properties of the intestine will also be examined.

Description

Malnutrition and sarcopenia are consequences of life-threatening gastroenterological diseases such as liver cirrhosis, chronic pancreatitis and short bowel syndrome and are associated with a poorer clinical outcome and a reduced quality of life. The diagnostic criteria of both conditions differ, as do the consequences for adequate nutritional therapy. Nevertheless, malnutrition and sarcopenia are often discussed in confusion in the literature. In addition, the underlying mechanisms of malnutrition and sarcopenia can differ in the various diseases. The aim of the study is to compare nutrition-associated parameters from patients with liver cirrhosis, chronic pancreatitis and short bowel syndrome, to characterize the disease-specific phenotype of malnutrition and sarcopenia of the examined diseases and to obtain information on mechanistic relationships. The pathophysiological understanding of the clinical settings as well as the development of malnutrition and sarcopenia is important for choosing specific nutritional therapies. For this, malnourished and non-malnourished patients of each examined disease are compared with controls from patients with non-specific, abdominal symptoms and healthy control subjects. Data on food intake, physical activity, body composition and anthropometry as well as muscle strength and muscle function are recorded. Clinical and chemical blood parameters, the plasma metabolome as well as transport and barrier proteins of the intestine are also examined.

Details

Condition	Cirrhosis, LIVER DISEASE, LIVER DISEASE, Short Bowel Syndrome, Chronic pancreatitis
Age	18years - 100years
Treatment	No intervention - cross-sectional observational only
Clinical Study Identifier	NCT04474743
Sponsor	University Medicine Greifswald
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Liver Cirrhosis
	based on clinical and imaging criteria (sonography or computed tomography (CT) or magnetic resonance imaging (MRI)) without evidence of hepatocellular carcinoma
	Child-Pugh Stadium A-C
	Chronic Pancreatitis
	based on imaging criteria (endoscopic ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), magnetic resonance cholangiopancreatography (MRCP))
	large and small duct disease
	with or without exocrine insufficiency
	with or without endocrine insufficiency
	patients after left pancreatic resection or pancreaticojejunostomy or duodenal pancreatic head resection
	Short Bowel Syndrome (SBS)
	based on clinical anamnestic criteria and state after bowel resection followed by primary or secondary oral autonomy (intestinal failure)
	Control Patients
	patients without known underlying gastroenterological disease with an indication for esophago-gastro-duodenoscopy for symptom clarification
	negative Nutritional Risk Screening (NRS-2002 < 3)
	gastroscopy without clinically relevant result (mild gastritis aspect, small axial hernia, typical glandular cysts, typical brunneromas can be included)
	Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
	General Exclusion Criteria
	parenteral nutrition in the previous 6 months
	pacemaker or implanted defibrillator
	pregnancy or lactation
	lack of ability to answer the questionnaires
	taking certain medications during the previous 4 weeks (protein pump inhibitors and H2 antagonists, except medication on demand or 4 weeks continuously, antibiotics, narcotics, non-opioid analgesics except medication on demand ( 1 day/week), anticholinergics, antidepressants, motility drugs (metoclopramide, motilium, bromocriptine, prucalopride), thyroid drugs except stable thyroid hormone substitution with euthyroid metabolism, steroids, immunomodulators, anti-inflammatory biologics)
	Subsequent Exclusion of Control Patients
	if, contrary to expectations, malnutrition is diagnosed in spite of an inconspicuous NRS-2002 within the framework of the study
	as well as in the case of relevant, conspicuous esophago-gastro-duodenoscopy findings
	Specific Exclusion Criteria
	Liver Cirrhosis
	steatohepatitis according to clinical or laboratory parameters
	acute alcoholic hepatitis according to clinical and imaging parameters (sonography, CT, MRI)
	existing transjugular intrahepatic portosystemic shunt (TIPS)
	known hepatocellular carcinoma (HCC)
	state after liver transplantation
	Chronic Pancreatitis
	acute pancreatitis
	extrapancreatic infection
	coexisting liver cirrhosis based on clinical and imaging parameters
	state after surgery with alteration of food flow (partial or total pancreaticoduodenectomy)
	known pancreatic carcinoma or state after therapy of pancreatic carcinoma (surgery or chemotherapy or radiation)
	Short Bowel Syndrome (SBS)
	acute phase of intestinal insufficiency (less than 28 days after resection)
	intravenous substitution of macronutrients (water, electrolytes, glucose, amino acids or lipids (intestinal insufficiency)
	intramuscular substitution of micronutrients is allowed (e.g. vitamin B12)
	uncontrolled underlying disease leading to SBS (e.g. active Crohn's disease)
	Control Patients
	major underlying and concomitant diseases
	food allergies
	Healthy controls
	tumor diseases in the past 5 years
	medically diagnosed, serious chronic diseases or changes in the gastrointestinal tract that may affect the absorption of nutrients (e.g. celiac disease, chronic inflammatory bowel disease or irritable bowel syndrome diagnosed according to Rome IV criteria, relevant bowel resections including short bowel syndrome)
	rheumatic diseases requiring permanent drug therapy (rheumatoid arthritis, fibromyalgia)
	chronic use of anti-inflammatory or pain-relieving drugs or use of anti-inflammatory or pain-relieving drugs for more than 3 days in the last 3 weeks
	average daily alcohol consumption > 20 g in women and > 30 g in men
	diagnosed severe liver disease requiring medical attention and drug therapy (liver cirrhosis, non-alcoholic steatohepatitis (NASH) / alcoholic steatohepatitis (ASH), hepatitides)
	acute or chronic pancreatitis
	acute and chronic renal failure
	myocardial infarction or cerebral insult within 6 months prior to examination
	coronary artery disease/pAVK (peripheral artery disease (PAD))
	heart failure with stages 3 and 4 according to NYHA (New York Heart Association) classification
	severe chronic pulmonary disease (COPD)
	history of significant neurological or psychiatric diseases (including epilepsy, bipolar disorders, dementia and neuromuscular diseases)
	presence of pareses including mono- and diparesis
	rare congenital metabolic diseases (cystic fibrosis, phenylketonuria)
	expected altered body composition (extreme sports activity < 2h/day), edema, amputation of the extremities (arm and/or leg)
	highly atypical or restrictive dietary choices/concepts followed voluntarily (macrobiotics, paleo-diet, Atkins diet, Mayo diet, instinctive diets) or due to food intolerances/allergies
	simultaneous participation in other studies associated with drug use and potentially having a significant impact on body composition or dietary behaviour

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ct scan

computed tomography

MRI

endoscopic ultrasound

cirrhosis

gastroscopy

gastrointestinal disorders

malnutrition

liver cirrhosis

hepatocellular carcinoma

body measurements

gastrointestinal disease

pancreaticojejunostomy

mrcp

magnetic resonance cholangiopancreatography

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Malnutrition in Chronic Gastrointestinal Diseases Cross-sectional Study