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

Not Applicable

• Conditions: Colorectal Cancer; Gastric Cancer
• Interventions: Dietary Supplement: Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science

• Registration Number: NCT04980950
• Lead Sponsor: Medical University of Gdansk

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-21
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-28
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-07-30
• Study Start: 2021-08-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gastric cancer patients (standard nutrition)	Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science	These patients will receive Nutridrink® Nutricia/ Resource 2.0 Nestlé Health Science for 10 days.
colorectal cancer patients (immunonutrition)	Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science	Experimental colorectal cancer group will receive Impact Oral Nestlé Health Science/ Cubitan® Nutricia for 10 days.
gastric cancer patients (immunonutrition)	Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science	Experimental gastric cancer group will receive Impact Oral Nestlé Health Science/ Cubitan® Nutricia for 10 days.
colorectal cancer patients (standard nutrition)	Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science	These patients will receive Nutridrink® Nutricia/ Resource 2.0 Nestlé Health Science for 10 days.

Primary Outcome Measures

Name	Time	Method
The impact of immunonutrition on gut microbiota in gastric and colorectal cancer patients.	at baseline and after 7 and 10 days	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

Name	Time	Method
The impact of immunonutrition on intestinal permeability in gastric and colorectal cancer patients.	at baseline and after 7 and 10 days	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.	at baseline and after 7 and 10 days	The calprotecin will be assessed. The unit is μg/g.