Gastric AdenocarcinomaPRONIC-GNCT06250075
Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer
A study testing Formulation with probiotics and Non-intervention for Clinical Outcomes -G5 in people with Gastric Adenocarcinoma and Gastric Cancer, run by Universidade Federal do Amazonas at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Gastric Cancer, Microbiome
- What is being tested?
- Formulation with probiotics and Non-intervention for Clinical Outcomes -G5
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Dec 2020to 26 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with indication for total or partial gastrectomy;
- Ages from 18 years old.
Who cannot join
- 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;
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Being tested
- Formulation with probiotics, Non-intervention for Clinical Outcomes -G5
- Keywords
- Gastric Cancer, Microbiome, Nutritional Status, Cytokines
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation with probioticsDietary supplement
Also called G1 Intervention Group, G3 Negative Control Group, Intervention for Clinical Outcomes -G4
Lactobacillus acidophilus NCFM®, Lactobacillus paracasei Lpc-37 ™, Bifidobacterium lactis Bi-04™, Bifidobacterium lactis Bi-07™, Bifidobacterium bifidum Bb-02™)
Non-intervention for Clinical Outcomes -G5Other
Also called Non-intervention
only observation of clinical outcomes in the postoperative period
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: 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. Receives: Other: Non-intervention for Clinical Outcomes -G5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: twelve months
Secondary outcomes (2)
Modulation of nutritional parameters with the use of probiotics-weight and height
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.
Measured: twelve months
Modulation of nutritional parameters using probiotics-phase angle
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
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start12 Dec 2020
- Primary completion4 Aug 2022
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Amazonas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abner Souza Paz, RD, Universidade Federal do Amazonas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250075
- Sponsor's protocol ID
- 6.014.436
- Acronym
- PRONIC-G
- Status last verified
- May 2024
- First submitted
- 5 Jan 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06250075
- Acronym / sponsor ID
- PRONIC-G / 6.014.436
- Keywords
- Gastric Cancer, Microbiome, Nutritional Status, Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Universidade Federal do AmazonasUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| G1 Intervention Group | Experimental | Dietary Supplement: Formulation with probioticsIn 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. |
| 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 | Dietary Supplement: Formulation with probioticsGroup 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 |
| Intervention for Clinical Outcomes -G4 | Active comparator | Dietary Supplement: Formulation with probioticsThe 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. |
| Non-intervention for Clinical Outcomes -G5 | Placebo comparator | Other: Non-intervention for Clinical Outcomes -G5G5 will use placebo capsules with 0.5g calcium carbonate to test the power of the intervention in reducing postoperative surgical complications or not. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with indication for total or partial gastrectomy;
- Ages from 18 years old.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formulation with probioticsAlso: G1 Intervention Group, G3 Negative Control Group, Intervention for Clinical Outcomes -G4Lactobacillus acidophilus NCFM®, Lactobacillus paracasei Lpc-37 ™, Bifidobacterium lactis Bi-04™, Bifidobacterium lactis Bi-07™, Bifidobacterium bifidum Bb-02™) | Dietary supplement | G1 Intervention Group, G3 Negative Control Group, Intervention for Clinical Outcomes -G4 |
| Non-intervention for Clinical Outcomes -G5Also: Non-interventiononly observation of clinical outcomes in the postoperative period | Other | Non-intervention for Clinical Outcomes -G5 |
Primary outcome
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.
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.
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.
2 secondary outcomes
Modulation of nutritional parameters with the use of probiotics-weight and height
Time frame: twelve months
Modulation of nutritional parameters using probiotics-phase angle
Time frame: twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formulation with probiotics and Non-intervention for Clinical Outcomes -G5 in people with Gastric Adenocarcinoma and Gastric Cancer, run by Universidade Federal do Amazonas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modulation of the Immune Response (time frame: twelve months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.