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

Colorectal Cancer Clinical Trial

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"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04980950
• Other study ID #: MUG
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

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