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Completed

NCT Number: NCT06250075

Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer

The objective of this randomized controlled, prospective clinical study, composed of 5 groups, G1, G2, G3, G4 and G5 is [Evaluate the intestinal microbiota profile, nutritional, immunological status and inflammatory profile, before and after total or partial removal surgery (gastrectomies) for gastric cancer, in a patient using probiotic supplements.] The main questions it aims to answer are:

* probiotics are capable of modulating the immune response and microbiota in cancer patients who will undergo surgery * surgery itself alters the immunological pattern and microbiota of cancer patients Participants will be divided into groups for evaluation and the G1 intervention group will take probiotic capsules.

The researchers will compare groups G1, G2 with G3 (negative control group) to see if there are differences between using probiotics or not, in controlling the immune response and if there are significant changes in their intestinal microbiota. Groups G4 and G5 will also be compared, where in these we will only measure the power of the use of probiotics in reducing surgical complications in the postoperative period.

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Key information

Conditions

Gastric Adenocarcinoma Cytokines Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Microbiome Neoplasms Neoplasms by Site Nutritional Status Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abner Souza Paz

Manaus, Amazonas, 69043160, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with indication for total or partial gastrectomy;
  • Ages from 18 years old.

Exclusion criteria

  • Palliative patients
  • Use of probiotics and prebiotics in the last 15 days;
  • Patients who are unable to complete all monitoring steps;
  • AIDS patients;
  • Diabetic patients;
  • Pregnant patients;
  • Patients with Autoimmune Diseases;
  • Patients with Liver Diseases;
  • Patients with Kidney Disease;
  • Patients with Inflammatory Bowel Diseases.
  • Patients who have MCP (pacemaker),
  • Patients with severe Edema,
  • Patients with titanium plates in any limb of the body
  • Patients who for some reason had their surgeries suspended during follow-up.
  • Patients undergoing mechanical colon preparation in the last 30 days.
  • Patients not resident/domiciled in Amazonas.

Treatment and study plan

Formulation with probiotics

Dietary Supplement

Lactobacillus acidophilus NCFM®, Lactobacillus paracasei Lpc-37 ™, Bifidobacterium lactis Bi-04™, Bifidobacterium lactis Bi-07™, Bifidobacterium bifidum Bb-02™)

Other names: G1 Intervention Group, G3 Negative Control Group, Intervention for Clinical Outcomes -G4

Non-intervention for Clinical Outcomes -G5

Other

only observation of clinical outcomes in the postoperative period

Other names: Non-intervention

Primary outcomes

  1. Modulation of the Immune Response

    Time frame: twelve months

    We will measure (measure the concentration) of inflammatory cytokines through flow cytometry, and then observe whether the intervention interferes negatively or positively in the inflammatory pattern.

  2. Modulation of the Intestinal Microbiota

    Time frame: twelve months

    The use of probiotics positively interfered in maintaining a change in the pre-surgical microbial profile, in relation to the post-surgical one.

  3. The use of probiotics can modify the incidence of postoperative complications

    Time frame: twelve months

    During surgery, many inflammatory factors can interfere with the appearance of postoperative complications. We assume that the use of probiotics can beneficially modulate surgical complications.

Secondary outcomes

  1. Modulation of nutritional parameters with the use of probiotics-weight and height

    Time frame: twelve months

    Nutritional measurements such as weight and height will be combined to obtain BMI and evaluate body mass, as biological markers that can be modulated with the use of probiotics.

  2. Modulation of nutritional parameters using probiotics-phase angle

    Time frame: twelve months

    Nutritional measurements such as phase angle (a measurement obtained by applying electrical bioimpendance, as a biological marker that can be modulated with the use of probiotics

Sponsors and collaborators

Lead sponsor

Universidade Federal do Amazonas

Other

Registry information

Official study title

Effects of the Use of Probiotics on the Intestinal Microbiota, Clinical-Nutritional and Immunological Status of Patients Gastrectomized for Gastric Cancer: A Randomized Clinical Trial

Acronym: PRONIC-G

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Feb 8, 2024
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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