Impact of Probiotics on the Intestinal Microbiota

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: Saccharomyces boulardii


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No intervention at all | |
| Experimental: Study group<br>Use of Saccharomyces boulardii, 100mg for at least seven days before surgery | Dietary Supplement: Saccharomyces boulardii<br>* 100mg daily for seven days prior to surgery<br>* Other names: Floratil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal cytokine | To assess mucosal cytokine levels | April 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short chain fatty acids | Assess mucosal short chain fatty acids | April 2013 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, cytokine, short chain fatty acids, complications, colorectal surgery