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

NCT06250075 | Completed DMC

• 1 other identifier: 6.014.436
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Adenocarcinoma; Gastric Cancer; Microbiome; Cytokines; Nutritional Status

Keywords

Gastric Cancer; Microbiome; Nutritional Status; Cytokines

Outcome Measures

Primary Outcomes (3)

• Modulation of the Immune Response

  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.

  twelve months

• Modulation of the Intestinal Microbiota

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

  twelve months

• The use of probiotics can modify the incidence of postoperative complications

  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.

  twelve months

Secondary Outcomes (2)

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

  twelve months

• Modulation of nutritional parameters using probiotics-phase angle

  twelve months

Study Arms (5)

G1 Intervention Group

EXPERIMENTAL

In group 1, the intervention will take place with intake from the 1st day Post-OP when releasing the diet (Orally or ENT) and up to 7 days post-operatively with probiotic capsules.

Dietary Supplement: Formulation with probiotics

Non-Intervention Group G2

NO INTERVENTION

Group G2 followed general nutritional guidelines. This group will not take probiotics, it will be the surgical comparator.

G3 Negative Control Group

SHAM COMPARATOR

Group G3 (guest employees) will follow the intake of probiotic capsules for 7 days during follow-up, without surgical intervention, these will be chosen at random and standardized by social level paired with G1

Dietary Supplement: Formulation with probiotics

Intervention for Clinical Outcomes -G4

ACTIVE COMPARATOR

The G4 and G5 groups will be recruited and randomized in the second stage of the research after the end of the collection of the G1 and G2 groups, for analysis of clinical outcomes in the 7-day postoperative period.

Dietary Supplement: Formulation with probiotics

Non-intervention for Clinical Outcomes -G5

PLACEBO COMPARATOR

G5 will use placebo capsules with 0.5g calcium carbonate to test the power of the intervention in reducing postoperative surgical complications or not.

Other: Non-intervention for Clinical Outcomes -G5

Interventions

Formulation with probiotics DIETARY_SUPPLEMENT

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

Also known as: G1 Intervention Group, G3 Negative Control Group, Intervention for Clinical Outcomes -G4

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

Also known as: Non-intervention

Non-intervention for Clinical Outcomes -G5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Amazonas: lead

Study Sites (1)

Abner Souza Paz

Manaus, Amazonas, 69043160, Brazil

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Dosage Forms; Probiotics; Methods

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: For the first stage of the research, patients eligible for cancer gastrectomies were invited at FCECON on an outpatient basis or through the surgical map on the day of admission. Randomization took place through a specific application called Randomizer for Clinical Trial Lite. Different wards were assigned to each group to avoid contact between research participants (G1 intervention and G2 non-intervention). For the G3 (control) group, they will be recruited by invitation, they must be FCECON employees, this group will specifically be matched by the socioeconomic level of the patients in the G1 group. The G4 and G5 groups will be recruited and randomized in the second stage of the research after the end of the collection of the G1 and G2 groups, for analysis of clinical outcomes in the 7-day postoperative period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In time 1 of the research, patients will be distributed through the Randomizer Clinical Trial Lite application into 4 groups (G1, G2, G4 and G5) to receive 1 capsule a day of probiotics (groups G1 and G4) will receive a formulation containing 20 billion of microorganisms. In group G2 (no intervention), treatment with standard nutrition, without the use of probiotics. The intervention product (probiotic capsules) will be distributed and packaged according to randomization for blinding. In the case of group G3 (control), they will receive probiotic capsules after the end of groups G1 and G2. Both groups that will use probiotic capsules, 1 capsule per day, in the same shift, must continue for 7 days, without interruption in monitoring. In relation to groups G4 and G5, they constitute time 2 of the research, with G4 being the group that will use probiotics following the G1 standard and G5 will use placebo capsules with 0.5g of calcium carbonate to test the power of the intervention.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 8, 2024
• Study Start: December 12, 2020
• Primary Completion: August 4, 2022
• Study Completion: April 26, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

BR (1)