Impact of Probiotics on the Intestinal Microbiota

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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Dietary supplement: Saccharomyces boulardii

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group; No intervention at all
EXPERIMENTAL: Study group; Use of Saccharomyces boulardii, 100mg for at least seven days before surgery	Dietary supplement: Saccharomyces boulardii; 100mg daily for seven days prior to surgery; Other Names: Floratil

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: Maria Isabel Correia, MD, PhD, UFMG

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: May 27, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (ESTIMATE): June 1, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 12, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: complications; probiotics; colorectal surgery; cytokine; short chain fatty acids
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CDS - APQ-01005-11 (OTHER_GRANT: FAPEMIG - CDS - APQ-01005-11)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Scientific publications