Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-12-31

Brief Summary

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

This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. The researchers will compare incidence of surgical site infection between the study groups.

Related Clinical Trials

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

Synbiotics and Gastrointestinal Function Related Quality of Life After Colectomy for Cancer

NCT01479907

Colorectal Neoplasms

COMPLETED NA

An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection

NCT06692179

Recurrent Clostridioides Difficile Infection Colonic Surgery

RECRUITING PHASE1

Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs: A Propensity Analysis

NCT04258098

Surgical Site Infection Colorectal Cancer

COMPLETED

Multimodal Prehabilitation for Colorectal Surgery

NCT01356264

Colorectal Cancer Colorectal Cancer Stage III

COMPLETED PHASE2

Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

NCT01777568

30% Oxygen Concentration During Colorectal Surgery 80% Oxygen Concentration During Colorectal Surgery

COMPLETED NA

Detailed Description

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

This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be randomly selected to receive either a symbiotic formulation or placebo during the perioperative period. The researchers will compare incidence of surgical site infection, detected by clinical examination and complementary tests (CT scans, X-rays, microbiological and hematological tests) between the study groups.

Conditions

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

Colorectal Cancer Surgical Site Infection

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

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

symbiotic group

Symbiotic group

Group Type EXPERIMENTAL

symbiotic group

Intervention Type DIETARY_SUPPLEMENT

this group received sachets of symbiotic

placebo group

Group Type PLACEBO_COMPARATOR

placebo group

Intervention Type DIETARY_SUPPLEMENT

this group received placebo

Interventions

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

symbiotic group

this group received sachets of symbiotic

Intervention Type DIETARY_SUPPLEMENT

placebo group

this group received placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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

maltodextrina

Eligibility Criteria

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

Inclusion Criteria

* Adults between 18 and 85 years old;
* Colorectal cancer patients.
* Ability to understand and signing the informed consent

Exclusion Criteria

* Pregnancy (early diagnosis)
* Reduced intellectual level that could prevent proper understanding of the objectives of the study
* Patients with rectal cancer undergoing neoadjuvant treatment (chemotherapy and radiotherapy)
* Use of products with prebiotic, probiotic and / or symbiotic function or fiber module; by more than 3x a week
* Refusal to participate and / or to sign the Consent Form Free and Clear

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No