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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastric Cancer, Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gastric cancer patients (immunonutrition)<br>Experimental gastric cancer group will receive Impact Oral Nestlé Health Science/ Cubitan® Nutricia for 10 days. | Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science<br>* 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.<br>|
| Active Comparator: gastric cancer patients (standard nutrition)<br>These patients will receive Nutridrink® Nutricia/ Resource 2.0 Nestlé Health Science for 10 days. | Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science<br>* 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.<br>|
| Experimental: colorectal cancer patients (immunonutrition)<br>Experimental colorectal cancer group will receive Impact Oral Nestlé Health Science/ Cubitan® Nutricia for 10 days. | Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science<br>* 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.<br>|
| Active Comparator: colorectal cancer patients (standard nutrition)<br>These patients will receive Nutridrink® Nutricia/ Resource 2.0 Nestlé Health Science for 10 days. | Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | at baseline and after 7 and 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at baseline and after 7 and 10 days | 
| The impact of immunonutrition on intestines in gastric and colorectal cancer patients. | The calprotecin will be assessed. The unit is μg/g. | at baseline and after 7 and 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut barrier integrity, enteral immunonutrition, gastric cancer, gut microbiota, colorectal cancer