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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04980950
Other study ID # MUG
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date July 1, 2022

Study information

Verified date July 2021
Source Medical University of Gdansk
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date July 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - age >18 y.o. - patients with gastric or colorectal cancer - patients treated in Department of Surgical Oncology, Medical University of Gdansk - 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


Intervention

Dietary Supplement:
Impact 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Gdansk

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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