Impact of Probiotics in Modulation of Intestinal Microbiota

Colorectal Cancer Clinical Trial

Official title:

Impact of Probiotics in Modulation of Intestinal Microbiota of Patients Undergoing a Resection Colonic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895530
• Other study ID #: ETIC 0391.0.203.000-09
• Status: Completed
• Phase: N/A
• First received: June 30, 2013
• Last updated: July 5, 2013
• Start date: July 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2013
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Brazil	UFMG Hospital	Belo horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Maria Isabel Toulson Davisson Correia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in gene expression of citokynes	Colonic mucosal specimens were analyzed to determine the mucosal expression pro?les of IL1B, IL12B, IL10, IL23A, INFG, IL17A and TNF.	15 days	No
Secondary	Postoperative complications	Postoperative complications assessed up to 30 days	30 days	No