Impact of Probiotics in Modulation of Intestinal Microbiota

Study Overview
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: Saccharomyces boulardii


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Conventional treatment with no probiotic supplementation | |
| Experimental: Probiotic group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications assessed up to 30 days | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, colorectal cancer, postoperative infection, immune function, bacterial translocation, gastrointestinal surgery