CClinicalTrials.gg
Status unknownNCT04980950Updated Jul 30, 2021

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

An interventional study of Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science in Gastric Cancer and Colorectal Cancer, sponsored by Medical University of Gdansk. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-07-30.

Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Gastric Cancer
  • Colorectal Cancer

Keywords

  • gut microbiota
  • gut barrier integrity
  • enteral immunonutrition
  • gastric cancer
  • colorectal cancer
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 80 is close to the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Medical University of Gdansk is the lead sponsor of 130 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • age \<18 y.o.
  • other types of cancer than gastric/colorectal cancer
  • the presence of inflammatory bowel disease
  • pregnancy
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    gastric cancer patients (immunonutrition)

    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

  • Active comparator
    gastric cancer patients (standard nutrition)

    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

  • Experimental
    colorectal cancer patients (immunonutrition)

    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

  • Active comparator
    colorectal cancer patients (standard nutrition)

    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

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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: at baseline and after 7 and 10 days

Secondary outcomes

  1. 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.

    Time frame: at baseline and after 7 and 10 days

  2. The impact of immunonutrition on intestines in gastric and colorectal cancer patients.

    The calprotecin will be assessed. The unit is μg/g.

    Time frame: at baseline and after 7 and 10 days

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04980950
Lead sponsor
Medical University of Gdansk
Responsible party
Karolina Kaźmierczak-Siedlecka (Karolina Kaźmierczak-Siedlecka (nutritionist, PhD), senior assistant, Department of Surgical Oncology, Medical University of Gdansk) — Principal investigator
First posted
Jul 28, 2021
Start date
Aug 1, 2021 (estimated)
Primary completion
Jun 1, 2022 (estimated)
Completion
Jul 1, 2022 (estimated)
Last update
Jul 30, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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