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Impact of Probiotics on the Intestinal Microbiota

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01609660
Enrollment
33
Registered
2012-06-01
Start date
2010-03-31
Completion date
2013-03-31
Last updated
2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

probiotics, cytokine, short chain fatty acids, complications, colorectal surgery

Brief summary

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; (2) assess postoperative complications, mainly infectious and mortality, as well as length of hospital stay

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.

Interventions

DIETARY_SUPPLEMENTSaccharomyces boulardii

100mg daily for seven days prior to surgery

Sponsors

Federal University of Minas Gerais
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* older than 18 years old * intend to undergo elective colon resection at the UFMG Hospital

Exclusion criteria

* Patients in use of steroids * Patients unable to receive the probiotics for, at least, 7 days before the operation * Changes to the operation strategy * Patients that discontinued probiotic use * Patients who had previously taken any probiotic or prebiotic

Design outcomes

Primary

MeasureTime frameDescription
Mucosal cytokineApril 2013To assess mucosal cytokine levels

Secondary

MeasureTime frameDescription
Short chain fatty acidsApril 2013Assess mucosal short chain fatty acids

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026