Impact of Probiotics in Modulation of Intestinal Microbiota

Not Applicable

Completed

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

• Registration Number: NCT01895530
• Lead Sponsor: Maria Isabel Toulson Davisson Correia

Brief Summary

The investigators would study about impact of the administration of probiotics in the intestinal mucosa of patients undergoing resection colic, by evaluating cytokine profile by quantitative real time PCR. The investigators believe that patients who use probiotic preoperative would provide cytokine profile less inflammatory than those of the control group.

Detailed Description

Samples of colorectal cancer-free mucosa derived from patients who underwent surgical resection were investigated. Quantitative real-time polymerase chain reaction (RT-qPCR) was used to determine expression levels of the following genes: IL10, IL1B, IL23A, TNF, IL12B, INFG, IL17A.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-08
• Study Completion: 2012-05
• Study First Submitted: 2013-06-30
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-05
• Last Update Submitted: 2013-07-05
• Study First Posted: 2013-07-10
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

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

Inclusion Criteria

• if he or she were older than 18 years
• intended to undergo elective CRC resection at UFMG Hospital

Exclusion Criteria

• Patients were excluded if they were not able to receive the probiotics seven days before the operation
• if colon resection was not performed due to changes in operation strategy, or if they discontinued probiotic use on their own or
• if they removed their consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	Saccharomyces boulardii	The patients received one oral lyophilized yeast capsule, each of which contains 100 mg (0,5 x 109 cfu/g) of Saccharomyces boulardii (Merck S.A., Biocodex, Beauvais, French), once a day. The treatment started at least seven days before surgery and stopped on the operation day.

Primary Outcome Measures

Name	Time	Method
Difference in gene expression of citokynes	15 days	Colonic mucosal specimens were analyzed to determine the mucosal expression profiles of IL1B, IL12B, IL10, IL23A, INFG, IL17A and TNF.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	30 days	Postoperative complications assessed up to 30 days

Trial Locations

Locations (1)

UFMG Hospital; 🇧🇷 Belo horizonte, Minas Gerais, Brazil