Impact of Probiotics in Modulation of Intestinal Microbiota

NCT01895530 | Completed DMC

• 1 other identifier: ETIC 0391.0.203.000-09
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Probiotics; colorectal cancer; postoperative infection; immune function; bacterial translocation; gastrointestinal surgery

Outcome Measures

Primary Outcomes (1)

• Difference in gene expression of citokynes

  Colonic mucosal specimens were analyzed to determine the mucosal expression profiles of IL1B, IL12B, IL10, IL23A, INFG, IL17A and TNF.

  15 days

Secondary Outcomes (1)

• Postoperative complications

  30 days

Study Arms (2)

Control group

NO INTERVENTION

Conventional treatment with no probiotic supplementation

Probiotic group

EXPERIMENTAL

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.

Dietary Supplement: Saccharomyces boulardii

Interventions

Saccharomyces boulardii DIETARY_SUPPLEMENT

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.

Probiotic group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Isabel Toulson Davisson Correia: lead

Study Sites (1)

UFMG Hospital

Belo Horizonte, Minas Gerais, 30640100, Brazil

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Isabel TD Correia, PhD

  Federal University of Minas Gerais

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD.

Study Record Dates

• First Submitted: June 30, 2013
• First Posted: July 10, 2013
• Study Start: July 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: May 1, 2012
• Last Updated: July 10, 2013

Record last verified: 2013-07

Locations

BR (1)