Impact of Probiotics on the Intestinal Microbiota

Phase 4

Completed

• Conditions: Colorectal Cancer
• Interventions: Dietary Supplement: Saccharomyces boulardii

• Registration Number: NCT01609660
• Lead Sponsor: Federal University of Minas Gerais

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2012-05-27
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-01
• Primary Completion: 2012-07
• Study Completion: 2013-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Saccharomyces boulardii	Use of Saccharomyces boulardii, 100mg for at least seven days before surgery

Primary Outcome Measures

Name	Time	Method
Mucosal cytokine	April 2013	To assess mucosal cytokine levels

Secondary Outcome Measures

Name	Time	Method
Short chain fatty acids	April 2013	Assess mucosal short chain fatty acids