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Impact of Probiotics on the Intestinal Microbiota and Its Association With Postoperative Outcome After Colorectal Surgery


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Impact of Probiotics on the Intestinal Microbiota and Its Association With Postoperative Outcome After Colorectal Surgery


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.


Inclusion Criteria:



- older than 18 years old;

- colorectal cancer

Exclusion Criteria:

- diabetes,

- renal or hepatic failure

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Mucosal cytokine

Outcome Description:

To assess mucosal cytokine levels

Outcome Time Frame:

April 2013

Safety Issue:

No

Authority:

Brazil: Ethics Committee

Study ID:

CDS - APQ-01005-11

NCT ID:

NCT01609660

Start Date:

March 2010

Completion Date:

March 2013

Related Keywords:

  • Colorectal Cancer
  • probiotics
  • cytokine
  • short chain fatty acids
  • complications
  • colorectal surgery
  • Colorectal Neoplasms

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