NCT01609660

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_4 colorectal-cancer

Timeline
Completed

Started Mar 2010

Typical duration for phase_4 colorectal-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

May 27, 2012

Last Update Submit

September 9, 2016

Conditions

Colorectal Cancer

Keywords

probioticscytokineshort chain fatty acidscomplicationscolorectal surgery

Outcome Measures

Primary Outcomes (1)

  • Mucosal cytokine

    To assess mucosal cytokine levels

    April 2013

Secondary Outcomes (1)

  • Short chain fatty acids

    April 2013

Study Arms (2)

Control group

NO INTERVENTION

No intervention at all

Study group

EXPERIMENTAL

Use of Saccharomyces boulardii, 100mg for at least seven days before surgery

Dietary Supplement: Saccharomyces boulardii

Interventions

Saccharomyces boulardiiDIETARY_SUPPLEMENT

100mg daily for seven days prior to surgery

Also known as: Floratil
Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than 18 years old
  • intend to undergo elective colon resection at the UFMG Hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Maria Isabel Correia, MD, PhD

    UFMG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery, responsible investigator

Study Record Dates

First Submitted

May 27, 2012

First Posted

June 1, 2012

Study Start

March 1, 2010

Primary Completion

July 1, 2012

Study Completion

March 1, 2013

Last Updated

September 12, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Scientific publications