Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study

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Brief Title

Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study

Official Title

Multi-center, Controlled Cross-sectional Analysis of the Phenotype of Malnutrition in Patients With Liver Cirrhosis, Chronic Pancreatitis and Short Bowel Syndrome (as Part of the Joint Project "Enteral Nutrition in Malnutrition Due to Diseases of the Gastrointestinal Tract: From Basic Understanding to an Innovative Treatment Concept" (EnErGie))

Brief 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.
    

Detailed 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.
    


Study Type

Observational


Primary Outcome

Sarcopenia

Secondary Outcome

 Malnutrition-Sarcopenia Score

Condition

Liver Cirrhoses

Intervention

No intervention - cross-sectional observational only

Study Arms / Comparison Groups

 Liver Cirrhosis
Description:  Patients diagnosed with liver cirrhosis.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

320

Start Date

October 2, 2018

Completion Date

May 31, 2021

Primary Completion Date

May 31, 2021

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Prof. Dr. med. Lamprecht, +493814947481, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT04474743

Organization ID

A 2018-0129


Responsible Party

Sponsor

Study Sponsor

University Medicine Greifswald

Collaborators

 University Medical Center Rostock

Study Sponsor

Prof. Dr. med. Lamprecht, Principal Investigator, University Medicine Rostock


Verification Date

July 2020