Impact of Probiotics on the Intestinal Microbiota and Its Association With Postoperative Outcome After Colorectal Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01609660
First received: May 27, 2012
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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; short chain fatty acids and the microbiota environment; (2) assess postoperative complications, mainly infectious and mortality, as well as length of hospital stay


Condition Intervention Phase
Colorectal Cancer
Dietary Supplement: Saccharomyces boulardii
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Probiotics on the Intestinal Microbiota and Its Association With Postoperative Outcome After Colorectal Surgery

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Mucosal cytokine [ Time Frame: April 2013 ] [ Designated as safety issue: No ]
    To assess mucosal cytokine levels


Secondary Outcome Measures:
  • Short chain fatty acids [ Time Frame: April 2013 ] [ Designated as safety issue: No ]
    Assess mucosal short chain fatty acids


Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
No intervention at all
Experimental: Study group
Use of Saccharomyces boulardii, 200mg for at least seven days before surgery
Dietary Supplement: Saccharomyces boulardii
200mg daily for seven days prior to surgery
Other Name: Floratil

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • older than 18 years old;
  • colorectal cancer

Exclusion Criteria:

  • diabetes,
  • renal or hepatic failure
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: May 27, 2012
Last Updated: January 3, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on April 16, 2014