Impact of Probiotics on the Intestinal Microbiota

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotics In Colorectal Cancer Patients

NCT00936572

Colorectal Cancer

COMPLETED PHASE2

Probiotics in the Prevention of Complications After Colorectal Surgery

NCT02313519

Postoperative Complications

COMPLETED PHASE4

Comparison of Probiotic Effects on the Outcomes of Patients After Colorectal Cancer Surgery

NCT07144475

Colorectal Cancer

COMPLETED PHASE4

Probiotics and Recovery From Gastrointestinal Surgery - 2

NCT04266106

Surgical Recovery

UNKNOWN PHASE3

The Impact of Probiotics on Bariatric Treatment Outcomes

NCT07258732

Obesity &Amp; Overweight

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

No intervention at all

Group Type NO_INTERVENTION

No interventions assigned to this group

Study group

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

Group Type EXPERIMENTAL

Saccharomyces boulardii

Intervention Type DIETARY_SUPPLEMENT

100mg daily for seven days prior to surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Saccharomyces boulardii

100mg daily for seven days prior to surgery

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Floratil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No