<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04476056</url>
  </required_header>
  <id_info>
    <org_study_id>BB 069/19</org_study_id>
    <nct_id>NCT04476056</nct_id>
  </id_info>
  <brief_title>Malnutrition in Chronic Pancreatitis, Trans-sectoral Study</brief_title>
  <official_title>Analysis of Trans-sectoral Nutritional Care of Malnourished Patients With Chronic Pancreatitis Over 6 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Applied Sciences Neubrandenburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medicine Greifswald</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Malnutrition and loss of muscle mass are common in patients with chronic pancreatitis.&#xD;
      However, there is only limited data on nutritional treatment. In this study, malnourished&#xD;
      patients with chronic pancreatitis will receive an intensified nutritional therapy to improve&#xD;
      nutritional status. The aim of the study is that malnutrition in patients with chronic&#xD;
      pancreatitis can be successfully treated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malnutrition and sarcopenia are common complications in chronic pancreatitis leading to&#xD;
      increased morbidity and mortality. Therefore nutritional therapy can be considered&#xD;
      imperative. However, there is limited evidence on the treatment of malnutrition in patients&#xD;
      with chronic pancreatitis. This study aims to investigate the effect of an intensified&#xD;
      nutritional therapy on nutritional status in malnourished patients with chronic pancreatitis.&#xD;
      By testing feasibility of this intensified therapy valuable recommendations for future&#xD;
      treatment of malnutrition in patients with chronic pancreatitis can be derived.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 28, 2019</start_date>
  <completion_date type="Anticipated">November 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Feasibility Study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) Criteria</measure>
    <time_frame>6 months</time_frame>
    <description>Changes from baseline prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria after 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) criteria</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dropout Rate</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Dropout Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to Oral Nutritional Supplements</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Compliance is assessed by a standardized telephone interview comparing recommended and current intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to Dietary Counselling</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Compliance is assessed via standardized telephone interview comparing scheduled and cancelled sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Prevalence of malnutrition according to the Global Leadership Initiative on Malnutrition criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sarcopenia according to EWGSOP 2 (European Working Group on Sarcopenia in Older People 2) criteria</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Prevalence of sarcopenia according to the European Working Group on Sarcopenia in Older People 2 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduced Body Mass Index</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in prevalence of reduced body mass index (&lt; 18,5 kg/m², &lt; 20 kg/m² if age &lt; 70 yrs, &lt; 22 kg/m² if age ≥ 70 yrs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduced Fat Free Mass Index</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in prevalence of reduced fat free mass index (≤ 15 kg/m² if female, ≤ 17 kg/m² if male)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduced Skeletal Muscle Mass Index</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in prevalence of reduced skeletal muscle mass index (≤ 6,42 kg/m² if female, ≤ 8,87 kg/m² if male)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduced Gait Speed</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in prevalence of reduced gait speed (&lt; 0,8 m/s)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduced Muscle Strength</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in prevalence of reduced muscle strength (&lt; 19,3 kg if female, &lt; 30,3 kg if male)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Weight</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in body weight measured in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes height measured in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in body mass index measured in kg/m^2 (calculated from the values obtained for body weight and height)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist Circumference</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in waist circumference measured in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip Circumference</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in hip circumference measured in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist-to-Hip Ratio</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triceps Skinfold Thickness</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in triceps skinfold thickness measured in millimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper Arm Circumference</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in upper arm circumference measured in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat Free Mass</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in fat free mass measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skeletal Muscle Mass</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat Mass</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in fat mass measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Body Water</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in total body water measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extracellular Water</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in extracellular water measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase Angle</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in phase angle measured by Bioelectrical Impedance Analysis (BIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy Intake</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in energy intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein Intake</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in protein intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carbohydrate Intake</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in carbohydrate intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat Intake</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in fat intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Fiber Intake</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in dietary fiber intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in metabolic equivalent of task per day and activity level are assessed by employment of the German version of the International Physical Activity Questionnaire (IPAQ) Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in hemoglobin level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in hematocrit level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Corpuscular Volume</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in mean corpuscular volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Corpuscular Hemoglobin Concentration</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in mean corpuscular hemoglobin concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reticulocyte Count</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in reticulocyte count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of sodium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of potassium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calcium</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of calcium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnesium</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of magnesium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phosphate</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of phosphate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate Transaminase</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of aspartate transferase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine Aminotransferase</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of alanine aminotransferase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gamma-glutamyl Transferase</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of gamma-glutamyl transferase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alkaline Phosphatase</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of alkaline phosphatase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilirubin</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of bilirubin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive Protein</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of C-reactive protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin-1 Beta</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in serum concentration of interleukin-1 beta</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin-6</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of interleukin-6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor Necrosis Factor Alpha</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in serum concentration of tumor necrosis factor alpha</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of albumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urea</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of urea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uric Acid</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of uric acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycated hemoglobin</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of glycated hemoglobin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in serum concentration of insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Cholesterol</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of total cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High-density Lipoprotein Cholesterol</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of high-density lipoprotein cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low-density Lipoprotein Cholesterol</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of high-density lipoprotein cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-essential Fatty Acids</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of non-essential fatty acids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zinc</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in serum concentration of zinc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in plasma concentration of iron</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand Grip Strength</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in maximal hand grip strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait Speed</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in gait speed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and Depression</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in anxiety and depression assessed by the German version of the Hospital Anxiety and Depression Scale (HADS-D). For both the anxiety and the depression subscale scores range from 0-21, with higher values indicating a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in fatigue assessed by the German version of the Fatigue Severity Scale (FSS). Scores range from 1-7, with higher values indicating a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loneliness</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in loneliness assessed by the German Version of the 6-item De Jong Gierveld Loneliness Scale. Scores range from 0-6, with higher values indicating worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal Microbiome</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in the intestinal microbiome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Metabolome</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in the plasma metabolome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Transcriptome</measure>
    <time_frame>28 days, 3 months, 6 months</time_frame>
    <description>Changes in the plasma transcriptome</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Chronic Pancreatitis</condition>
  <condition>Malnutrition</condition>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>Chronic Pancreatitis + Malnutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Malnourished patients with chronic pancreatitis will receive intensified nutritional therapy for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intensified Nutritional Therapy</intervention_name>
    <description>Intensified nutritional therapy will begin in the hospital setting and comprises intake of a commercial oral nutritional supplement (Fortimel Compact 2.4, Nutricia) twice per day as well as personalized dietary counselling. After discharge, supplementation will be continued for at least 28 days and if necessary throughout the entire study duration. Likewise, dietary counselling will be provided throughout the entire study period based on the patient's individual need. Dietary counselling is provided either face-to-face during the follow-up visits or remotely via telephone between visits.</description>
    <arm_group_label>Chronic Pancreatitis + Malnutrition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic pancreatitis verified by histology or imaging modality (endoscopic ultrasound,&#xD;
             computed tomography, magnetic resonance imaging, magnetic resonance&#xD;
             cholangiopancreatography)&#xD;
&#xD;
          -  Diagnosis of malnutrition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Implanted defibrillator or pacemaker&#xD;
&#xD;
          -  History of pancreatic Cancer&#xD;
&#xD;
          -  Any other malignant tumor disease within the last 3 years&#xD;
&#xD;
          -  Concomitant liver cirrhosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prof. Dr. med. Markus M. Lerch</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medicine Greifswald</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Prof. Dr. med. Markus M. Lerch</last_name>
    <phone>+493834867230</phone>
    <email>markus.lerch@med.uni-greifswald.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Medicine Greifswald</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. Dr. med. Markus M. Lerch</last_name>
      <phone>+493834867230</phone>
      <email>markus.lerch@med.uni-greifswald.de</email>
    </contact>
    <investigator>
      <last_name>Ali A Aghdassi, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Simone Gärtner, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mats Wiese, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Pancreatitis, Chronic</mesh_term>
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04476056
org study id: BB 069/19
nct id: NCT04476056
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Malnutrition and loss of muscle mass are common in patients with chronic pancreatitis.
      However, there is only limited data on nutritional treatment. In this study, malnourished
      patients with chronic pancreatitis will receive an intensified nutritional therapy to improve
      nutritional status. The aim of the study is that malnutrition in patients with chronic
      pancreatitis can be successfully treated.
Malnutrition and sarcopenia are common complications in chronic pancreatitis leading to
      increased morbidity and mortality. Therefore nutritional therapy can be considered
      imperative. However, there is limited evidence on the treatment of malnutrition in patients
      with chronic pancreatitis. This study aims to investigate the effect of an intensified
      nutritional therapy on nutritional status in malnourished patients with chronic pancreatitis.
      By testing feasibility of this intensified therapy valuable recommendations for future
      treatment of malnutrition in patients with chronic pancreatitis can be derived.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Feasibility Study
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) Criteria
time frame: 6 months
description: Changes from baseline prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria after 6 months
measure: Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) criteria
time frame: 28 days, 3 months, 6 months
description: Prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria
measure: Dropout Rate
time frame: 28 days, 3 months, 6 months
description: Dropout Rate
measure: Compliance to Oral Nutritional Supplements
time frame: 28 days, 3 months, 6 months
description: Compliance is assessed by a standardized telephone interview comparing recommended and current intake
measure: Compliance to Dietary Counselling
time frame: 28 days, 3 months, 6 months
description: Compliance is assessed via standardized telephone interview comparing scheduled and cancelled sessions
measure: Malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria
time frame: 28 days, 3 months, 6 months
description: Prevalence of malnutrition according to the Global Leadership Initiative on Malnutrition criteria
measure: Sarcopenia according to EWGSOP 2 (European Working Group on Sarcopenia in Older People 2) criteria
time frame: 28 days, 3 months, 6 months
description: Prevalence of sarcopenia according to the European Working Group on Sarcopenia in Older People 2 criteria
measure: Reduced Body Mass Index
time frame: 28 days, 3 months, 6 months
description: Changes in prevalence of reduced body mass index (< 18,5 kg/m², < 20 kg/m² if age < 70 yrs, < 22 kg/m² if age ≥ 70 yrs)
measure: Reduced Fat Free Mass Index
time frame: 28 days, 3 months, 6 months
description: Changes in prevalence of reduced fat free mass index (≤ 15 kg/m² if female, ≤ 17 kg/m² if male)
measure: Reduced Skeletal Muscle Mass Index
time frame: 28 days, 3 months, 6 months
description: Changes in prevalence of reduced skeletal muscle mass index (≤ 6,42 kg/m² if female, ≤ 8,87 kg/m² if male)
measure: Reduced Gait Speed
time frame: 28 days, 3 months, 6 months
description: Changes in prevalence of reduced gait speed (< 0,8 m/s)
measure: Reduced Muscle Strength
time frame: 28 days, 3 months, 6 months
description: Changes in prevalence of reduced muscle strength (< 19,3 kg if female, < 30,3 kg if male)
measure: Body Weight
time frame: 28 days, 3 months, 6 months
description: Changes in body weight measured in kilograms
measure: Height
time frame: 28 days, 3 months, 6 months
description: Changes height measured in centimeters
measure: Body Mass Index
time frame: 28 days, 3 months, 6 months
description: Changes in body mass index measured in kg/m^2 (calculated from the values obtained for body weight and height)
measure: Waist Circumference
time frame: 28 days, 3 months, 6 months
description: Changes in waist circumference measured in centimeters
measure: Hip Circumference
time frame: 28 days, 3 months, 6 months
description: Changes in hip circumference measured in centimeters
measure: Waist-to-Hip Ratio
time frame: 28 days, 3 months, 6 months
description: Changes in waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)
measure: Triceps Skinfold Thickness
time frame: 28 days, 3 months, 6 months
description: Changes in triceps skinfold thickness measured in millimeters
measure: Upper Arm Circumference
time frame: 28 days, 3 months, 6 months
description: Changes in upper arm circumference measured in centimeters
measure: Fat Free Mass
time frame: 28 days, 3 months, 6 months
description: Changes in fat free mass measured by Bioelectrical Impedance Analysis (BIA)
measure: Skeletal Muscle Mass
time frame: 28 days, 3 months, 6 months
description: Changes in skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)
measure: Fat Mass
time frame: 28 days, 3 months, 6 months
description: Changes in fat mass measured by Bioelectrical Impedance Analysis (BIA)
measure: Total Body Water
time frame: 28 days, 3 months, 6 months
description: Changes in total body water measured by Bioelectrical Impedance Analysis (BIA)
measure: Extracellular Water
time frame: 28 days, 3 months, 6 months
description: Changes in extracellular water measured by Bioelectrical Impedance Analysis (BIA)
measure: Phase Angle
time frame: 28 days, 3 months, 6 months
description: Changes in phase angle measured by Bioelectrical Impedance Analysis (BIA)
measure: Energy Intake
time frame: 28 days, 3 months, 6 months
description: Changes in energy intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)
measure: Protein Intake
time frame: 28 days, 3 months, 6 months
description: Changes in protein intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)
measure: Carbohydrate Intake
time frame: 28 days, 3 months, 6 months
description: Changes in carbohydrate intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)
measure: Fat Intake
time frame: 28 days, 3 months, 6 months
description: Changes in fat intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)
measure: Dietary Fiber Intake
time frame: 28 days, 3 months, 6 months
description: Changes in dietary fiber intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)
measure: Physical Activity
time frame: 28 days, 3 months, 6 months
description: Changes in metabolic equivalent of task per day and activity level are assessed by employment of the German version of the International Physical Activity Questionnaire (IPAQ) Short Form
measure: Hemoglobin
time frame: 28 days, 3 months, 6 months
description: Changes in hemoglobin level
measure: Hematocrit
time frame: 28 days, 3 months, 6 months
description: Changes in hematocrit level
measure: Mean Corpuscular Volume
time frame: 28 days, 3 months, 6 months
description: Changes in mean corpuscular volume
measure: Mean Corpuscular Hemoglobin Concentration
time frame: 28 days, 3 months, 6 months
description: Changes in mean corpuscular hemoglobin concentration
measure: Reticulocyte Count
time frame: 28 days, 3 months, 6 months
description: Changes in reticulocyte count
measure: Sodium
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of sodium
measure: Potassium
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of potassium
measure: Calcium
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of calcium
measure: Magnesium
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of magnesium
measure: Phosphate
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of phosphate
measure: Aspartate Transaminase
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of aspartate transferase
measure: Alanine Aminotransferase
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of alanine aminotransferase
measure: Gamma-glutamyl Transferase
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of gamma-glutamyl transferase
measure: Alkaline Phosphatase
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of alkaline phosphatase
measure: Bilirubin
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of bilirubin
measure: C-reactive Protein
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of C-reactive protein
measure: Interleukin-1 Beta
time frame: 28 days, 3 months, 6 months
description: Changes in serum concentration of interleukin-1 beta
measure: Interleukin-6
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of interleukin-6
measure: Tumor Necrosis Factor Alpha
time frame: 28 days, 3 months, 6 months
description: Changes in serum concentration of tumor necrosis factor alpha
measure: Albumin
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of albumin
measure: Creatinine
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of creatinine
measure: Urea
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of urea
measure: Uric Acid
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of uric acid
measure: Glucose
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of glucose
measure: Glycated hemoglobin
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of glycated hemoglobin
measure: Insulin
time frame: 28 days, 3 months, 6 months
description: Changes in serum concentration of insulin
measure: Total Cholesterol
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of total cholesterol
measure: High-density Lipoprotein Cholesterol
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of high-density lipoprotein cholesterol
measure: Low-density Lipoprotein Cholesterol
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of high-density lipoprotein cholesterol
measure: Triglycerides
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of triglycerides
measure: Non-essential Fatty Acids
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of non-essential fatty acids
measure: Zinc
time frame: 28 days, 3 months, 6 months
description: Changes in serum concentration of zinc
measure: Iron
time frame: 28 days, 3 months, 6 months
description: Changes in plasma concentration of iron
measure: Hand Grip Strength
time frame: 28 days, 3 months, 6 months
description: Changes in maximal hand grip strength
measure: Gait Speed
time frame: 28 days, 3 months, 6 months
description: Changes in gait speed
measure: Anxiety and Depression
time frame: 28 days, 3 months, 6 months
description: Changes in anxiety and depression assessed by the German version of the Hospital Anxiety and Depression Scale (HADS-D). For both the anxiety and the depression subscale scores range from 0-21, with higher values indicating a worse outcome.
measure: Fatigue
time frame: 28 days, 3 months, 6 months
description: Changes in fatigue assessed by the German version of the Fatigue Severity Scale (FSS). Scores range from 1-7, with higher values indicating a better outcome.
measure: Loneliness
time frame: 28 days, 3 months, 6 months
description: Changes in loneliness assessed by the German Version of the 6-item De Jong Gierveld Loneliness Scale. Scores range from 0-6, with higher values indicating worse outcome.
measure: Intestinal Microbiome
time frame: 28 days, 3 months, 6 months
description: Changes in the intestinal microbiome
measure: Plasma Metabolome
time frame: 28 days, 3 months, 6 months
description: Changes in the plasma metabolome
measure: Plasma Transcriptome
time frame: 28 days, 3 months, 6 months
description: Changes in the plasma transcriptome
arm group label: Chronic Pancreatitis + Malnutrition
arm group type: Experimental
description: Malnourished patients with chronic pancreatitis will receive intensified nutritional therapy for 6 months.
intervention type: Other
intervention name: Intensified Nutritional Therapy
description: Intensified nutritional therapy will begin in the hospital setting and comprises intake of a commercial oral nutritional supplement (Fortimel Compact 2.4, Nutricia) twice per day as well as personalized dietary counselling. After discharge, supplementation will be continued for at least 28 days and if necessary throughout the entire study duration. Likewise, dietary counselling will be provided throughout the entire study period based on the patient's individual need. Dietary counselling is provided either face-to-face during the follow-up visits or remotely via telephone between visits.
arm group label: Chronic Pancreatitis + Malnutrition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Prof. Dr. med. Markus M. Lerch
role: Principal Investigator
affiliation: University Medicine Greifswald
last name: Prof. Dr. med. Markus M. Lerch
phone: +493834867230
email: markus.lerch@med.uni-greifswald.de
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Pancreatitis
mesh term: Pancreatitis, Chronic
mesh term: Sarcopenia
mesh term: Malnutrition