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Completed

NCT Number: NCT01895530

Impact of Probiotics in Modulation of Intestinal Microbiota

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UFMG Hospital

Belo Horizonte, Minas Gerais, 30640100, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Difference in gene expression of citokynes

    Time frame: 15 days

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

Secondary outcomes

  1. Postoperative complications

    Time frame: 30 days

    Postoperative complications assessed up to 30 days

Sponsors and collaborators

Lead sponsor

Maria Isabel Toulson Davisson Correia

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 10, 2013
Registry last updated
Jul 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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