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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04980950
Enrollment
80
Registered
2021-07-28
Start date
2021-08-01
Completion date
2022-07-01
Last updated
2021-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Gastric Cancer

Keywords

gut microbiota, gut barrier integrity, enteral immunonutrition, gastric cancer, colorectal cancer

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.

Interventions

DIETARY_SUPPLEMENTImpact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science

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.

Sponsors

Medical University of Gdansk
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The impact of immunonutrition on gut microbiota in gastric and colorectal cancer patients.at baseline and after 7 and 10 daysThe 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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026