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"The Impact of Immunonutrition on Gut Microbiota-related Aspects in Colorectal Cancer and Gastric Cancer Patients"

Primary Purpose

Gastric Cancer, Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring gut microbiota, gut barrier integrity, enteral immunonutrition, gastric cancer, colorectal cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age >18 y.o.
  • patients with gastric or colorectal cancer
  • patients treated in Department of Surgical Oncology, Medical University of Gdańsk
  • patients' agreement to take part in this study

Exclusion Criteria:

  • age <18 y.o.
  • other types of cancer than gastric/colorectal cancer
  • the presence of inflammatory bowel disease
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    gastric cancer patients (immunonutrition)

    gastric cancer patients (standard nutrition)

    colorectal cancer patients (immunonutrition)

    colorectal cancer patients (standard nutrition)

    Arm Description

    Experimental gastric cancer group will receive Impact Oral Nestlé Health Science/ Cubitan® Nutricia for 10 days.

    These patients will receive Nutridrink® Nutricia/ Resource 2.0 Nestlé Health Science for 10 days.

    Experimental colorectal cancer group will receive Impact Oral Nestlé Health Science/ Cubitan® Nutricia for 10 days.

    These patients will receive Nutridrink® Nutricia/ Resource 2.0 Nestlé Health Science for 10 days.

    Outcomes

    Primary Outcome Measures

    The impact of immunonutrition on gut microbiota in gastric and colorectal cancer patients.
    The composition of gut microbiota (bacteria and fungi) will be assessed from stools. The amounts of bacteria/fungi will be presented using bioinformatics tools and there is no precisely described units (only the total number).

    Secondary Outcome Measures

    The impact of immunonutrition on intestinal permeability in gastric and colorectal cancer patients.
    The ratio lactulose/mannitol will be described to assess intestinal permeability. There is no units. Only ratio of two numbers.
    The impact of immunonutrition on intestines in gastric and colorectal cancer patients.
    The calprotecin will be assessed. The unit is μg/g.

    Full Information

    First Posted
    April 21, 2021
    Last Updated
    July 29, 2021
    Sponsor
    Medical University of Gdansk
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04980950
    Brief Title
    "The Impact of Immunonutrition on Gut Microbiota-related Aspects in Colorectal Cancer and Gastric Cancer Patients"
    Official Title
    "The Impact of Enteral Immunonutrition on Gut Microbiota, Intestinal Permeability, and Inflammation of Intestines in Colorectal Cancer as Well as Gastric Cancer Patients - a Randomized Trials"
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    June 1, 2022 (Anticipated)
    Study Completion Date
    July 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Gdansk

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Enteral immunomodulating nutrition modifies the gastrointestinal microbiota as well as improves the intestinal barrier integrity in patients with gastric and colorectal cancer in the perioperative period. As a consequence, it contributes to the reduction of the incidence of postoperative complications and diarrhea, which is a side effect of anti-cancer treatment often used preoperatively in this group of cancers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer, Colorectal Cancer
    Keywords
    gut microbiota, gut barrier integrity, enteral immunonutrition, gastric cancer, colorectal cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    gastric cancer patients (immunonutrition)
    Arm Type
    Experimental
    Arm Description
    Experimental gastric cancer group will receive Impact Oral Nestlé Health Science/ Cubitan® Nutricia for 10 days.
    Arm Title
    gastric cancer patients (standard nutrition)
    Arm Type
    Active Comparator
    Arm Description
    These patients will receive Nutridrink® Nutricia/ Resource 2.0 Nestlé Health Science for 10 days.
    Arm Title
    colorectal cancer patients (immunonutrition)
    Arm Type
    Experimental
    Arm Description
    Experimental colorectal cancer group will receive Impact Oral Nestlé Health Science/ Cubitan® Nutricia for 10 days.
    Arm Title
    colorectal cancer patients (standard nutrition)
    Arm Type
    Active Comparator
    Arm Description
    These patients will receive Nutridrink® Nutricia/ Resource 2.0 Nestlé Health Science for 10 days.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science
    Intervention Description
    Gastric and colorectal cancer patients will receive 1 bottle of immunonutrition or standard nutrition for 10 days. The aims of this study is to assess the effects of these immunonutrition on gut microbiota, intestinal permeability as well as inflammation of intestines in gastric and colorectal cancer patients.
    Primary Outcome Measure Information:
    Title
    The impact of immunonutrition on gut microbiota in gastric and colorectal cancer patients.
    Description
    The composition of gut microbiota (bacteria and fungi) will be assessed from stools. The amounts of bacteria/fungi will be presented using bioinformatics tools and there is no precisely described units (only the total number).
    Time Frame
    at baseline and after 7 and 10 days
    Secondary Outcome Measure Information:
    Title
    The impact of immunonutrition on intestinal permeability in gastric and colorectal cancer patients.
    Description
    The ratio lactulose/mannitol will be described to assess intestinal permeability. There is no units. Only ratio of two numbers.
    Time Frame
    at baseline and after 7 and 10 days
    Title
    The impact of immunonutrition on intestines in gastric and colorectal cancer patients.
    Description
    The calprotecin will be assessed. The unit is μg/g.
    Time Frame
    at baseline and after 7 and 10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age >18 y.o. patients with gastric or colorectal cancer patients treated in Department of Surgical Oncology, Medical University of Gdańsk patients' agreement to take part in this study Exclusion Criteria: age <18 y.o. other types of cancer than gastric/colorectal cancer the presence of inflammatory bowel disease pregnancy

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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