Clinical Trials Directory

Trials / Completed

CompletedNCT01609660

Impact of Probiotics on the Intestinal Microbiota

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
33 (actual)
Sponsor
Federal University of Minas Gerais · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTSaccharomyces boulardii100mg daily for seven days prior to surgery

Timeline

Start date
2010-03-01
Primary completion
2012-07-01
Completion
2013-03-01
First posted
2012-06-01
Last updated
2016-09-12

Source: ClinicalTrials.gov record NCT01609660. Inclusion in this directory is not an endorsement.