<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/NCT03795870</url>
  </required_header>
  <id_info>
    <org_study_id>18-004416</org_study_id>
    <nct_id>NCT03795870</nct_id>
  </id_info>
  <brief_title>Enteral Nutrition Tolerance and the Gut Microbiome Study</brief_title>
  <official_title>The Effect of Blenderized Tube Feeding on Enteral Nutrition Tolerance and the Gut Microbiome: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The current study will enroll patients who are going to require enteral nutrition support for&#xD;
      at least 4 weeks and randomize them to standard polymeric formulas or blenderized tube&#xD;
      feeding. They will be asked to fill out a questionnaire about their tolerance of enteral&#xD;
      feeds. They will also be asked to provide stool samples before enrollment and after 4-6&#xD;
      weeks.&#xD;
&#xD;
      The study is trying to assess whether the use of whole food in blenderized tube feeding will&#xD;
      be better tolerated and also lead to greater diversity of microbiome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malnutrition remains highly prevalent in both acute and chronic diseases, leading to longer&#xD;
      hospital length of stay, greater risk of hospital readmission, and overall increase in&#xD;
      morbidity and mortality. Over the last few decades, studies have continued to reveal&#xD;
      significant clinical benefit from nutrition support, including reduction in complications and&#xD;
      length of stay, maintenance of gastrointestinal integrity, and overall improvement in&#xD;
      clinical outcomes and mortality. Despite high prevalence of Home Enteral Nutrition(HEN),&#xD;
      patients continue to struggle with intolerance of tube feeds leading to chronic underfeeding&#xD;
      and weight loss. Current guidelines recommend using standard polymeric formula or&#xD;
      high-protein standard formula in the hospitalized patient requiring EN and also recommend&#xD;
      against routine use of formulas designed to be immune-modulatory, elemental/semi-elemental,&#xD;
      disease-specific (diabetes), and organ-specific (hepatic, renal, pulmonary).&#xD;
&#xD;
      Blenderized Tube Feeding(BTF) offers a number of advantages to standard polymeric formula&#xD;
      including being able to modify the macro-nutrient and fiber content based on patient&#xD;
      preference. BTF use has also been increasing significantly in the past few years.&#xD;
&#xD;
      The gut microbiome, or gut host environment, consists of approximately 10 thousand cells and&#xD;
      has been the subject of much interest as it relates to gastrointestinal homeostasis. Our aim&#xD;
      therefore is to (1) characterize the structure and dynamics of complex microbial communities&#xD;
      using 16S rRNA- encoding gene sequences; (2) determine how they change with EN and; (3) how&#xD;
      they may be correlated with tolerance of EN.&#xD;
&#xD;
      A total of fifty subjects who are willing to participate in current trial and who meet&#xD;
      eligibility will be recruited from the Mayo Clinic HEN program. Suitable subjects will be&#xD;
      identified when they present at the initial HEN visit prior to undergoing enteral tube&#xD;
      placement.&#xD;
&#xD;
      Written informed consent will be obtained from all individuals who participate in the study.&#xD;
      The principal investigator or member of study team meet with each participant, review the&#xD;
      consent form in detail and confirm the subject's understanding of the study. The study team&#xD;
      will answer all questions posed by the participants and when convinced that the subject&#xD;
      verbally demonstrates understanding of the protocol, they will obtain a signed consent. Only&#xD;
      designated staff members are authorized to obtain informed consent.&#xD;
&#xD;
      At the pre-enteral tube visit, subjects will complete a gastrointestinal quality of life&#xD;
      (QoL) questionnaire which will form the baseline assessment for symptoms and functional&#xD;
      status. Body composition will be measured using Bio-impedance analysis (BIA; InBody™). A&#xD;
      stool specimen will be obtained for analysis of the gut microbiome at baseline. Baseline&#xD;
      clinical data such as current medical problems will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 7, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective Randomized Controlled</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The randomization list will be generated using http://www.randomization.com and the investigator team will be blinded at enrollment using supplement codes. A designated study coordinator will hold the randomization codes and the codes will be revealed to the investigators only after the statistical analysis is complete.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of goal calories provided</measure>
    <time_frame>4-6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gut microbiome</measure>
    <time_frame>1 week, 4-6 weeks</time_frame>
    <description>A stool specimen will be collected to assess the composition of the gut microbiome at baseline and at the follow-up visit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Enteral Feeding Intolerance</condition>
  <arm_group>
    <arm_group_label>Polymeric Tube Feeds</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will be receiving Polymeric Tube Feeds as a part of the regular HEN Protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blenderized Tube Feeds</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will be receiving Blenderized tube feeds as a part of the regular HEN Protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Polymeric Tube Feeds</intervention_name>
    <description>Polymeric tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with blenderized tube feeds</description>
    <arm_group_label>Polymeric Tube Feeds</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Blenderized Tube Feeds</intervention_name>
    <description>Blenderized tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with polymeric tube feeds</description>
    <arm_group_label>Blenderized Tube Feeds</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All subjects who are above 18 years of age, who present to Mayo Clinic HEN program for&#xD;
             initial evaluation prior to enteral tube placement&#xD;
&#xD;
          2. Require enteral nutrition support for at least 4-6 weeks from enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with type 1 or 2 diabetes will be excluded due to the known pre-existing&#xD;
             changes in the gut microbiome in this population.&#xD;
&#xD;
          2. Patients who have had exposure to probiotics, prebiotics or antibiotics in the&#xD;
             preceding 4 weeks will be excluded.&#xD;
&#xD;
          3. Known allergy or intolerance to study products will be excluded.&#xD;
&#xD;
          4. Patients on parenteral nutrition will be excluded.&#xD;
&#xD;
          5. If oral feeding accounts for &gt;25% of daily caloric intake.&#xD;
&#xD;
          6. Presence of entero-cutaneous fistula&#xD;
&#xD;
          7. Patients with short bowel syndrome will be excluded.&#xD;
&#xD;
          8. Patients who have had bariatric surgery or other alteration of GI tract will be&#xD;
             excluded.&#xD;
&#xD;
          9. Hematologic malignancy with absolute neutrophil count &lt; 500/mm3&#xD;
&#xD;
         10. History of renal or liver transplant or on transplant list.&#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>Manpreet S Mundi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Manpreet S Mundi, MD</last_name>
    <phone>507-284-0106</phone>
    <email>Mundi.Manpreet@mayo.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vishakantha (Vishu) Murthy, PhD</last_name>
    <phone>507-255-8112</phone>
    <email>Murthy.Vishakantha@mayo.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manpreet Mundi, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mayo.edu/research/clinical-trials/</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Manpreet S. Mundi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Home Enteral Nutrition</keyword>
  <keyword>Gut Microbiome</keyword>
  <keyword>Blenderized Tube Feeds</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03795870
org study id: 18-004416
nct id: NCT03795870
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The current study will enroll patients who are going to require enteral nutrition support for
      at least 4 weeks and randomize them to standard polymeric formulas or blenderized tube
      feeding. They will be asked to fill out a questionnaire about their tolerance of enteral
      feeds. They will also be asked to provide stool samples before enrollment and after 4-6
      weeks.

      The study is trying to assess whether the use of whole food in blenderized tube feeding will
      be better tolerated and also lead to greater diversity of microbiome.
Malnutrition remains highly prevalent in both acute and chronic diseases, leading to longer
      hospital length of stay, greater risk of hospital readmission, and overall increase in
      morbidity and mortality. Over the last few decades, studies have continued to reveal
      significant clinical benefit from nutrition support, including reduction in complications and
      length of stay, maintenance of gastrointestinal integrity, and overall improvement in
      clinical outcomes and mortality. Despite high prevalence of Home Enteral Nutrition(HEN),
      patients continue to struggle with intolerance of tube feeds leading to chronic underfeeding
      and weight loss. Current guidelines recommend using standard polymeric formula or
      high-protein standard formula in the hospitalized patient requiring EN and also recommend
      against routine use of formulas designed to be immune-modulatory, elemental/semi-elemental,
      disease-specific (diabetes), and organ-specific (hepatic, renal, pulmonary).

      Blenderized Tube Feeding(BTF) offers a number of advantages to standard polymeric formula
      including being able to modify the macro-nutrient and fiber content based on patient
      preference. BTF use has also been increasing significantly in the past few years.

      The gut microbiome, or gut host environment, consists of approximately 10 thousand cells and
      has been the subject of much interest as it relates to gastrointestinal homeostasis. Our aim
      therefore is to (1) characterize the structure and dynamics of complex microbial communities
      using 16S rRNA- encoding gene sequences; (2) determine how they change with EN and; (3) how
      they may be correlated with tolerance of EN.

      A total of fifty subjects who are willing to participate in current trial and who meet
      eligibility will be recruited from the Mayo Clinic HEN program. Suitable subjects will be
      identified when they present at the initial HEN visit prior to undergoing enteral tube
      placement.

      Written informed consent will be obtained from all individuals who participate in the study.
      The principal investigator or member of study team meet with each participant, review the
      consent form in detail and confirm the subject's understanding of the study. The study team
      will answer all questions posed by the participants and when convinced that the subject
      verbally demonstrates understanding of the protocol, they will obtain a signed consent. Only
      designated staff members are authorized to obtain informed consent.

      At the pre-enteral tube visit, subjects will complete a gastrointestinal quality of life
      (QoL) questionnaire which will form the baseline assessment for symptoms and functional
      status. Body composition will be measured using Bio-impedance analysis (BIA; InBody™). A
      stool specimen will be obtained for analysis of the gut microbiome at baseline. Baseline
      clinical data such as current medical problems will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective Randomized Controlled
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
masking description: The randomization list will be generated using http://www.randomization.com and the investigator team will be blinded at enrollment using supplement codes. A designated study coordinator will hold the randomization codes and the codes will be revealed to the investigators only after the statistical analysis is complete.
measure: Percentage of goal calories provided
time frame: 4-6 weeks
measure: Gut microbiome
time frame: 1 week, 4-6 weeks
description: A stool specimen will be collected to assess the composition of the gut microbiome at baseline and at the follow-up visit.
arm group label: Polymeric Tube Feeds
arm group type: Active Comparator
description: This arm will be receiving Polymeric Tube Feeds as a part of the regular HEN Protocol.
arm group label: Blenderized Tube Feeds
arm group type: Active Comparator
description: This arm will be receiving Blenderized tube feeds as a part of the regular HEN Protocol.
intervention type: Dietary Supplement
intervention name: Polymeric Tube Feeds
description: Polymeric tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with blenderized tube feeds
arm group label: Polymeric Tube Feeds
intervention type: Dietary Supplement
intervention name: Blenderized Tube Feeds
description: Blenderized tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with polymeric tube feeds
arm group label: Blenderized Tube Feeds
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Manpreet S Mundi, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Manpreet S Mundi, MD
phone: 507-284-0106
email: Mundi.Manpreet@mayo.edu
last name: Vishakantha (Vishu) Murthy, PhD
phone: 507-255-8112
email: Murthy.Vishakantha@mayo.edu
facility: 
status: Recruiting
contact: 
country: United States
url: http://www.mayo.edu/research/clinical-trials/
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Manpreet S. Mundi
investigator title: Principal Investigator
sharing ipd: No