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Clinical Trials/NCT01609660
NCT01609660
Completed
Phase 4

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

Federal University of Minas Gerais0 sites33 target enrollmentMarch 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Federal University of Minas Gerais
Enrollment
33
Primary Endpoint
Mucosal cytokine
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
March 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Minas Gerais
Responsible Party
Principal Investigator
Principal Investigator

Maria Isabel Toulson Davisson Correia

Professor of Surgery, responsible investigator

Federal University of Minas Gerais

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

Outcomes

Primary Outcomes

Mucosal cytokine

Time Frame: April 2013

To assess mucosal cytokine levels

Secondary Outcomes

  • Short chain fatty acids(April 2013)

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