Impact of Probiotics on the Intestinal Microbiota and Its Association With Postoperative Outcome After Colorectal Surgery
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Purpose
The purpose of this study is to assess the impact of probiotic administration (Saccharomyces boulardii) on patients undergoing colorectal resections comparing to the routine protocol by assessing: (1)intestinal microbiota modulation using RT-PCR to measure cytokine in the mucosa; short chain fatty acids and the microbiota environment; (2) assess postoperative complications, mainly infectious and mortality, as well as length of hospital stay
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Dietary Supplement: Saccharomyces boulardii |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Impact of Probiotics on the Intestinal Microbiota and Its Association With Postoperative Outcome After Colorectal Surgery |
- Mucosal cytokine [ Time Frame: April 2013 ] [ Designated as safety issue: No ]To assess mucosal cytokine levels
- Short chain fatty acids [ Time Frame: April 2013 ] [ Designated as safety issue: No ]Assess mucosal short chain fatty acids
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | March 2013 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control group
No intervention at all
|
|
|
Experimental: Study group
Use of Saccharomyces boulardii, 200mg for at least seven days before surgery
|
Dietary Supplement: Saccharomyces boulardii
200mg daily for seven days prior to surgery
Other Name: Floratil
|
Detailed Description:
The intestinal microbiota, a complex and dynamic population of different bacterial species, under normal circumstances, represents an important contribution to the health of the host. This plays a key role by maintaining the integrity of the epithelial barrier and helping the development of mucosal immunity. However, under some stressful situations, such as after gastrointestinal surgery, infectious complications may be originated from the patient's own intestinal microbiota. This leads to the so called "gut origin of sepsis" hypothesis. On the other hand, under similar conditions, the supply of probiotics, the good bacteria, has been shown to be beneficial, despite few controversial results. Therefore, it is important to carefully assess the efficacy of probiotics in the prevention and treatment of complications in surgical patients, as well as to evaluate the safety of its use.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- older than 18 years old;
- colorectal cancer
Exclusion Criteria:
- diabetes,
- renal or hepatic failure
Contacts and Locations More Information
No publications provided
| Responsible Party: | Maria Isabel Toulson Davisson Correia, Professor of Surgery, responsible investigator, Federal University of Minas Gerais |
| ClinicalTrials.gov Identifier: | NCT01609660 History of Changes |
| Other Study ID Numbers: | CDS - APQ-01005-11, CDS - APQ-01005-11 |
| Study First Received: | May 27, 2012 |
| Last Updated: | January 3, 2013 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Federal University of Minas Gerais:
|
probiotics cytokine short chain fatty acids complications colorectal surgery |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013