Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

All Drugs and Chemicals

Gastrointestinal Agents

Bone Density Conservation Agents

Other Dietary Supplements

Calcium

Calcium Carbonate

Calcium, Dietary

Acidophilus

Bifidobacterium

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

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.

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

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

Formulation with probiotics

only observation of clinical outcomes in the postoperative period

Non-intervention for Clinical Outcomes -G5

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.

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.

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.

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

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

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.

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

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.

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer	NCT06250075	Gastric Adenoca... Gastric Cancer Microbiome Cytokines Nutritional Sta...	Formulation wit... Non-interventio...	18 Years -	Universidade Federal do Amazonas
Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer	NCT06250075	Gastric Adenoca... Gastric Cancer Microbiome Cytokines Nutritional Sta...	Formulation wit... Non-interventio...	18 Years -	Universidade Federal do Amazonas

Spots Global Cancer Trial Database for formulation with probiotics