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Trial record 87 of 228 for:    yeast

Impact of Probiotics in Modulation of Intestinal Microbiota

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ClinicalTrials.gov Identifier: NCT01895530
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : July 10, 2013
Sponsor:
Information provided by (Responsible Party):
Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Dietary Supplement: Saccharomyces boulardii Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of Probiotics in Modulation of Intestinal Microbiota of Patients Undergoing a Resection Colonic
Study Start Date : July 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : May 2012

Arm Intervention/treatment
No Intervention: Control group
Conventional treatment with no probiotic supplementation
Experimental: 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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days ]
    Postoperative complications assessed up to 30 days



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895530


Locations
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Brazil
UFMG Hospital
Belo horizonte, Minas Gerais, Brazil, 30640100
Sponsors and Collaborators
Maria Isabel Toulson Davisson Correia
Investigators
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Study Director: Isabel TD Correia, PhD Federal University of Minas Gerais

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Responsible Party: Maria Isabel Toulson Davisson Correia, PhD., Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01895530     History of Changes
Other Study ID Numbers: ETIC 0391.0.203.000-09
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: July 2013
Keywords provided by Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais:
Probiotics
colorectal cancer
postoperative infection
immune function
bacterial translocation
gastrointestinal surgery
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases