Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

Change in Incidence of Surgical Site Infection After Resection of Colorectal Cancer Between Patients Receiving a Symbiotic Compound and Patients Receiving a Placebo.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02571374

Enrollment

Registered

2015-10-08

Start date

2013-10-31

Completion date

2016-12-31

Last updated

2015-10-08

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

Conditions

Colorectal Cancer, Surgical Site Infection

Keywords

symbiotic, colorectal cancer

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTsymbiotic group

this group received sachets of symbiotic

DIETARY_SUPPLEMENTplacebo group

this group received placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with colorectal cancer on symbiotic to prevent postoperative infection	1 month	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. After we will compare the number of participants with incidence of surgical site infection between the study groups.

Countries

Brazil

Contacts

Primary ContactAline Taborda, ms

alinegamarrat@hotmail.com555130849948

Backup ContactDaniel Damin, dr

damin@terra.com.br55 51 3359-8000

Outcome results

None listed

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