Back to resultsImpact of Probiotics in Modulation of Intestinal Microbiota
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Saccharomyces boulardii
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer focused on measuring Probiotics, colorectal cancer, postoperative infection, immune function, bacterial translocation, gastrointestinal surgery
Eligibility Criteria
Inclusion Criteria:
- if he or she were older than 18 years
- intended to undergo elective CRC resection at UFMG Hospital
Exclusion Criteria:
- 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.
Sites / Locations
- UFMG Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Probiotic group
Arm Description
Conventional treatment with no probiotic supplementation
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Postoperative complications
Postoperative complications assessed up to 30 days
Full Information
NCT ID
NCT01895530
First Posted
June 30, 2013
Last Updated
July 5, 2013
Sponsor
Maria Isabel Toulson Davisson Correia
1. Study Identification
Unique Protocol Identification Number
NCT01895530
Brief Title
Impact of Probiotics in Modulation of Intestinal Microbiota
Official Title
Impact of Probiotics in Modulation of Intestinal Microbiota of Patients Undergoing a Resection Colonic
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maria Isabel Toulson Davisson Correia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Probiotics, colorectal cancer, postoperative infection, immune function, bacterial translocation, gastrointestinal surgery
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Conventional treatment with no probiotic supplementation
Arm Title
Probiotic group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Saccharomyces boulardii
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in gene expression of citokynes
Description
Colonic mucosal specimens were analyzed to determine the mucosal expression profiles of IL1B, IL12B, IL10, IL23A, INFG, IL17A and TNF.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Postoperative complications assessed up to 30 days
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
if he or she were older than 18 years
intended to undergo elective CRC resection at UFMG Hospital
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel TD Correia, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Director
Facility Information:
Facility Name
UFMG Hospital
City
Belo horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30640100
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Impact of Probiotics in Modulation of Intestinal Microbiota
We'll reach out to this number within 24 hrs