Impact of Probiotics in Modulation of Intestinal Microbiota

NCT ID: NCT01895530

Last Updated: 2013-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control group

Conventional treatment with no probiotic supplementation

Group Type NO_INTERVENTION

No interventions assigned to this group

Probiotic group

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.

Group Type EXPERIMENTAL

Saccharomyces boulardii

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maria Isabel Toulson Davisson Correia

OTHER

Sponsor Role lead

Responsible Party

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Maria Isabel Toulson Davisson Correia

PhD.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Isabel TD Correia, PhD

Role: STUDY_DIRECTOR

Federal University of Minas Gerais

Locations

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UFMG Hospital

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ETIC 0391.0.203.000-09

Identifier Type: -

Identifier Source: org_study_id

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