Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study

University Medicine Greifswald

Status: Completed

Conditions: Liver Cirrhoses; Chronic Pancreatitis; Short Bowel Syndrome

Treatments: Other: No intervention - cross-sectional observational only

Study type: Observational

Funder types: Other

Identifiers

NCT04474743

A 2018-0129

Details and patient eligibility

About

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.

Full 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.

Enrollment: 345 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

345 participants in 5 patient groups

Liver Cirrhosis

Description:

Patients diagnosed with liver cirrhosis.

Treatment:

Other: No intervention - cross-sectional observational only

Chronic Pancreatitis

Description:

Patients diagnosed with chronic pancreatitis.

Treatment:

Other: No intervention - cross-sectional observational only

Short Bowel Syndrome

Description:

Patients diagnosed with short bowel Syndrome.

Treatment:

Other: No intervention - cross-sectional observational only

Control Patients

Description:

Otherwise healthy patients visiting hospital with other non-severe diseases.

Treatment:

Other: No intervention - cross-sectional observational only

Healthy Controls

Description:

Healthy subjects recruited from the general population.

Treatment:

Other: No intervention - cross-sectional observational only