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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-12

Study Completion Date

2024-04-26

Brief Summary

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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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Detailed Description

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Conditions

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Gastric Adenocarcinoma Gastric Cancer Microbiome Cytokines Nutritional Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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G1 Intervention Group

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.

Group Type EXPERIMENTAL

Formulation with probiotics

Intervention Type DIETARY_SUPPLEMENT

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

Non-Intervention Group G2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

G3 Negative Control Group

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

Group Type SHAM_COMPARATOR

Formulation with probiotics

Intervention Type DIETARY_SUPPLEMENT

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

Intervention for Clinical Outcomes -G4

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.

Group Type ACTIVE_COMPARATOR

Formulation with probiotics

Intervention Type DIETARY_SUPPLEMENT

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

Non-intervention for Clinical Outcomes -G5

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

Group Type PLACEBO_COMPARATOR

Non-intervention for Clinical Outcomes -G5

Intervention Type OTHER

only observation of clinical outcomes in the postoperative period

Interventions

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Formulation with probiotics

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

Intervention Type DIETARY_SUPPLEMENT

Non-intervention for Clinical Outcomes -G5

only observation of clinical outcomes in the postoperative period

Intervention Type OTHER

Other Intervention Names

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G1 Intervention Group G3 Negative Control Group Intervention for Clinical Outcomes -G4 Non-intervention

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No