Colorectal CancerNCT01895530
Impact of Probiotics in Modulation of Intestinal Microbiota
A study testing Saccharomyces boulardii in people with Colorectal Cancer, run by Maria Isabel Toulson Davisson Correia at 1 site in Brazil.
Trial summary
The investigators would study about impact of the administration of probiotics in the intestinal mucosa of patients undergoing resection colic, by evaluating cytokine profile by quantitative real time PCR. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Saccharomyces boulardii
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to May 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- if he or she were older than 18 years
- intended to undergo elective CRC resection at UFMG Hospital
Who cannot join
- Patients were excluded if they were not able to receive the probiotics seven days before the operation
- if colon resection was not performed due to changes in operation strategy, or if they discontinued probiotic use on their own or
- if they removed their consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Probiotics in Modulation of Intestinal Microbiota of Patients Undergoing a Resection Colonic
The investigators would study about impact of the administration of probiotics in the intestinal mucosa of patients undergoing resection colic, by evaluating cytokine profile by quantitative real time PCR. The investigators believe that patients who use probiotic preoperative would provide cytokine profile less inflammatory than those of the control group.
Read the detailed description
Samples of colorectal cancer-free mucosa derived from patients who underwent surgical resection were investigated. Quantitative real-time polymerase chain reaction (RT-qPCR) was used to determine expression levels of the following genes: IL10, IL1B, IL23A, TNF, IL12B, INFG, IL17A.
- Conditions
- Colorectal Cancer
- Being tested
- Saccharomyces boulardii
- Keywords
- Probiotics, colorectal cancer, postoperative infection, immune function, bacterial translocation, gastrointestinal surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces boulardiiDietary supplement
The patients received one oral lyophilized yeast capsule, each of which contains 100 mg (0,5 x 109 cfu/g) of Saccharomyces boulardii (Merck S.A., Biocodex, Beauvais, French), once a day. The treatment started at least seven days before surgery and stopped on the operation day.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Conventional treatment with no probiotic supplementation |
| Probiotic group | Experimental | The patients received one oral lyophilized yeast capsule, each of which contains 100 mg (0,5 x 109 cfu/g) of Saccharomyces boulardii (Merck S.A., Biocodex, Beauvais, French), once a day. The treatment started at least seven days before surgery and stopped on the operation day. Receives: Dietary Supplement: Saccharomyces boulardii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in gene expression of citokynes
Colonic mucosal specimens were analyzed to determine the mucosal expression profiles of IL1B, IL12B, IL10, IL23A, INFG, IL17A and TNF.
Measured: 15 days
Secondary outcomes (1)
Postoperative complications
Postoperative complications assessed up to 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJul 2010
- Primary completionAug 2011
- Study completionMay 2012
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Isabel Toulson Davisson Correia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
- Investigators
- Isabel TD Correia, PhD, Study director, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895530
- Sponsor's protocol ID
- ETIC 0391.0.203.000-09
- Status last verified
- Jul 2013
- First submitted
- 30 Jun 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Probiotics in Modulation of Intestinal Microbiota of Patients Undergoing a Resection Colonic
- ClinicalTrials.gov ID
- NCT01895530
- Acronym / sponsor ID
- ETIC 0391.0.203.000-09
- Conditions
- Colorectal Cancer
- Keywords
- Probiotics, colorectal cancer, postoperative infection, immune function, bacterial translocation, gastrointestinal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Maria Isabel Toulson Davisson CorreiaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Jul 2013 (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.
The investigators would study about impact of the administration of probiotics in the intestinal mucosa of patients undergoing resection colic, by evaluating cytokine profile by quantitative real time PCR. The investigators believe that patients who use probiotic preoperative would provide cytokine profile less inflammatory than those of the control group.
Detailed description
Samples of colorectal cancer-free mucosa derived from patients who underwent surgical resection were investigated. Quantitative real-time polymerase chain reaction (RT-qPCR) was used to determine expression levels of the following genes: IL10, IL1B, IL23A, TNF, IL12B, INFG, IL17A.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Conventional treatment with no probiotic supplementation |
| Probiotic group | Experimental | Dietary Supplement: Saccharomyces boulardiiThe patients received one oral lyophilized yeast capsule, each of which contains 100 mg (0,5 x 109 cfu/g) of Saccharomyces boulardii (Merck S.A., Biocodex, Beauvais, French), once a day. The treatment started at least seven days before surgery and stopped on the operation day. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- if he or she were older than 18 years
- intended to undergo elective CRC resection at UFMG Hospital
Key exclusion criteria (3 listed)
- Patients were excluded if they were not able to receive the probiotics seven days before the operation
- if colon resection was not performed due to changes in operation strategy, or if they discontinued probiotic use on their own or
- if they removed their consent.
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 |
|---|---|---|
| Saccharomyces boulardiiThe patients received one oral lyophilized yeast capsule, each of which contains 100 mg (0,5 x 109 cfu/g) of Saccharomyces boulardii (Merck S.A., Biocodex, Beauvais, French), once a day. The treatment started at least seven days before surgery and stopped on the operation day. | Dietary supplement | Probiotic group |
Primary outcome
Difference in gene expression of citokynes
Time frame: 15 days
Colonic mucosal specimens were analyzed to determine the mucosal expression profiles of IL1B, IL12B, IL10, IL23A, INFG, IL17A and TNF.
1 secondary outcome
Postoperative complications
Time frame: 30 days
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 10 Jul 2013.
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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.
Isabel TD Correia, PhD study director
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saccharomyces boulardii in people with Colorectal Cancer, run by Maria Isabel Toulson Davisson Correia 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 3 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 10 Jul 2013. 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. 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?
Difference in gene expression of citokynes (time frame: 15 days). 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 10 Jul 2013.