Impact of Probiotics on the Intestinal Microbiota
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Saccharomyces boulardii
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring probiotics, cytokine, short chain fatty acids, complications, colorectal surgery
Eligibility Criteria
Inclusion Criteria:
- older than 18 years old
- intend to undergo elective colon resection at the UFMG Hospital
Exclusion Criteria:
- Patients in use of steroids
- Patients unable to receive the probiotics for, at least, 7 days before the operation
- Changes to the operation strategy
- Patients that discontinued probiotic use
- Patients who had previously taken any probiotic or prebiotic
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Study group
Arm Description
No intervention at all
Use of Saccharomyces boulardii, 100mg for at least seven days before surgery
Outcomes
Primary Outcome Measures
Mucosal cytokine
To assess mucosal cytokine levels
Secondary Outcome Measures
Short chain fatty acids
Assess mucosal short chain fatty acids
Full Information
NCT ID
NCT01609660
First Posted
May 27, 2012
Last Updated
September 9, 2016
Sponsor
Federal University of Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT01609660
Brief Title
Impact of Probiotics on the Intestinal Microbiota
Official Title
Impact of Probiotics on the Intestinal Microbiota and Its Association With Postoperative Outcome After Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the impact of probiotic administration (Saccharomyces boulardii) on patients undergoing colorectal resections comparing to the routine protocol by assessing: (1)intestinal microbiota modulation using RT-PCR to measure cytokine in the mucosa; (2) assess postoperative complications, mainly infectious and mortality, as well as length of hospital stay
Detailed Description
The intestinal microbiota, a complex and dynamic population of different bacterial species, under normal circumstances, represents an important contribution to the health of the host. This plays a key role by maintaining the integrity of the epithelial barrier and helping the development of mucosal immunity. However, under some stressful situations, such as after gastrointestinal surgery, infectious complications may be originated from the patient's own intestinal microbiota. This leads to the so called "gut origin of sepsis" hypothesis. On the other hand, under similar conditions, the supply of probiotics, the good bacteria, has been shown to be beneficial, despite few controversial results. Therefore, it is important to carefully assess the efficacy of probiotics in the prevention and treatment of complications in surgical patients, as well as to evaluate the safety of its use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
probiotics, cytokine, short chain fatty acids, complications, colorectal surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
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
No intervention at all
Arm Title
Study group
Arm Type
Experimental
Arm Description
Use of Saccharomyces boulardii, 100mg for at least seven days before surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Saccharomyces boulardii
Other Intervention Name(s)
Floratil
Intervention Description
100mg daily for seven days prior to surgery
Primary Outcome Measure Information:
Title
Mucosal cytokine
Description
To assess mucosal cytokine levels
Time Frame
April 2013
Secondary Outcome Measure Information:
Title
Short chain fatty acids
Description
Assess mucosal short chain fatty acids
Time Frame
April 2013
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
older than 18 years old
intend to undergo elective colon resection at the UFMG Hospital
Exclusion Criteria:
Patients in use of steroids
Patients unable to receive the probiotics for, at least, 7 days before the operation
Changes to the operation strategy
Patients that discontinued probiotic use
Patients who had previously taken any probiotic or prebiotic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Isabel Correia, MD, PhD
Organizational Affiliation
UFMG
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Scientific publications
Learn more about this trial
Impact of Probiotics on the Intestinal Microbiota
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