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Impact of Probiotics on the Intestinal Microbiota

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ClinicalTrials.gov Identifier: NCT01609660
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : September 12, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Dietary Supplement: Saccharomyces boulardii Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Probiotics on the Intestinal Microbiota and Its Association With Postoperative Outcome After Colorectal Surgery
Study Start Date : March 2010
Primary Completion Date : July 2012
Study Completion Date : March 2013
Arms and Interventions

Arm Intervention/treatment
No Intervention: Control group
No intervention at all
Experimental: Study group
Use of Saccharomyces boulardii, 100mg for at least seven days before surgery
Dietary Supplement: Saccharomyces boulardii
100mg daily for seven days prior to surgery
Other Name: Floratil


Outcome Measures

Primary Outcome Measures :
  1. Mucosal cytokine [ Time Frame: April 2013 ]
    To assess mucosal cytokine levels


Secondary Outcome Measures :
  1. Short chain fatty acids [ Time Frame: April 2013 ]
    Assess mucosal short chain fatty acids


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609660


Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Principal Investigator: Maria Isabel Correia, MD, PhD UFMG
More Information

Responsible Party: Maria Isabel Toulson Davisson Correia, Professor of Surgery, responsible investigator, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01609660     History of Changes
Other Study ID Numbers: CDS - APQ-01005-11
CDS - APQ-01005-11 ( Other Grant/Funding Number: FAPEMIG - CDS - APQ-01005-11 )
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Scientific publications

Keywords provided by Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais:
probiotics
cytokine
short chain fatty acids
complications
colorectal surgery

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases