Impact of Probiotics on the Intestinal Microbiota

Federal University of Minas Gerais

Status and phase: Completed; Phase 4

Conditions: Colorectal Cancer

Treatments: Dietary Supplement: Saccharomyces boulardii

Study type: Interventional

Funder types: Other

Identifiers

NCT01609660

CDS - APQ-01005-11 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Control group

No Intervention group

Description:

No intervention at all

Study group

Experimental group

Description:

Use of Saccharomyces boulardii, 100mg for at least seven days before surgery

Treatment:

Dietary Supplement: Saccharomyces boulardii