Colorectal CancerNCT02571374
Symbiotics to Prevent Postoperative Infection in Colorectal Cancer
A study testing symbiotic group in people with Colorectal Cancer and Surgical Site Infection, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. The researchers will compare incidence of surgical site infection between the study groups. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer, Surgical Site Infection
- What is being tested?
- symbiotic group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Dec 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 18 and 85 years old;
- Colorectal cancer patients.
- Ability to understand and signing the informed consent
Who cannot join
- Pregnancy (early diagnosis)
- Reduced intellectual level that could prevent proper understanding of the objectives of the study
- Patients with rectal cancer undergoing neoadjuvant treatment (chemotherapy and radiotherapy)
- Use of products with prebiotic, probiotic and / or symbiotic function or fiber module; by more than 3x a week
- Refusal to participate and / or to sign the Consent Form Free and Clear
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 91770-545
aline taborda, ms, 5191065005, alinegamarrat@hotmail.com
About this study
Official title: Change in Incidence of Surgical Site Infection After Resection of Colorectal Cancer Between Patients Receiving a Symbiotic Compound and Patients Receiving a Placebo.
This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. The researchers will compare incidence of surgical site infection between the study groups.
Read the detailed description
This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be randomly selected to receive either a symbiotic formulation or placebo during the perioperative period. The researchers will compare incidence of surgical site infection, detected by clinical examination and complementary tests (CT scans, X-rays, microbiological and hematological tests) between the study groups.
- Conditions
- Colorectal Cancer, Surgical Site Infection
- Being tested
- symbiotic group, placebo group
- Keywords
- symbiotic, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
symbiotic groupDietary supplement
this group received sachets of symbiotic
placebo groupDietary supplement
Also called maltodextrina
this group received placebo
| Study group | Role | What they receive |
|---|---|---|
| symbiotic group | Experimental | Symbiotic group Receives: Dietary Supplement: symbiotic group |
| placebo group | Placebo comparator | placebo group Receives: Dietary Supplement: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with colorectal cancer on symbiotic to prevent postoperative infection
This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. After we will compare the number of participants with incidence of surgical site infection between the study groups.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Gamarra Taborda, Hospital de Clinicas de Porto Alegre
- Investigators
- Aline Taborda, ms, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571374
- Sponsor's protocol ID
- symbioticcolorectalcancer
- Status last verified
- Oct 2015
- First submitted
- 11 Apr 2014
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Incidence of Surgical Site Infection After Resection of Colorectal Cancer Between Patients Receiving a Symbiotic Compound and Patients Receiving a Placebo.
- ClinicalTrials.gov ID
- NCT02571374
- Acronym / sponsor ID
- symbioticcolorectalcancer
- Conditions
- Colorectal Cancer, Surgical Site Infection
- Keywords
- symbiotic, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Oct 2015 (estimated)
- 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.
This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. The researchers will compare incidence of surgical site infection between the study groups.
Detailed description
This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be randomly selected to receive either a symbiotic formulation or placebo during the perioperative period. The researchers will compare incidence of surgical site infection, detected by clinical examination and complementary tests (CT scans, X-rays, microbiological and hematological tests) between the study groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| symbiotic group | Experimental | Dietary Supplement: symbiotic groupSymbiotic group |
| placebo group | Placebo comparator | Dietary Supplement: placebo groupplacebo group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults between 18 and 85 years old;
- Colorectal cancer patients.
- Ability to understand and signing the informed consent
Key exclusion criteria (5 listed)
- Pregnancy (early diagnosis)
- Reduced intellectual level that could prevent proper understanding of the objectives of the study
- Patients with rectal cancer undergoing neoadjuvant treatment (chemotherapy and radiotherapy)
- Use of products with prebiotic, probiotic and / or symbiotic function or fiber module; by more than 3x a week
- Refusal to participate and / or to sign the Consent Form Free and Clear
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 |
|---|---|---|
| symbiotic groupthis group received sachets of symbiotic | Dietary supplement | symbiotic group |
| placebo groupAlso: maltodextrinathis group received placebo | Dietary supplement | placebo group |
Primary outcome
Number of participants with colorectal cancer on symbiotic to prevent postoperative infection
Time frame: 1 month
This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. After we will compare the number of participants with incidence of surgical site infection between the study groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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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.
Aline Taborda, ms principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing symbiotic group in people with Colorectal Cancer and Surgical Site Infection, run by Hospital de Clinicas de Porto Alegre 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Oct 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aline Taborda, ms (555130849948, alinegamarrat@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with colorectal cancer on symbiotic to prevent postoperative infection (time frame: 1 month). 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 8 Oct 2015.