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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
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 27, 2012
    Last Updated
    September 9, 2016
    Sponsor
    Federal University of Minas Gerais
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    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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