Impact of Symbiotic Administration on Intestinal Function of Head and Neck Patients Surgically Treated

Federal University of Minas Gerais40 enrolled

Overview

The purpose of this study is to determine whether the symbiotic use in patients with head and neck cancer impact on intestinal function after surgical treatment.

The study will be conducted offering the patients symbiotic product twice a day for seven days after the surgical treatment. Patients will be monitored for the number of stools, stools consistency, abdominal pain and gas overproduction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Head and Neck Cancer Synbiotics Nutrition Therapy

Interventions

SymbioticDIETARY_SUPPLEMENT

Intervention will consist of the adminitration of symbiotic product twice a day during seven days after surgical treatment

MaltodextrinDIETARY_SUPPLEMENT

Intervention will consist of the adminitration of placebo product twice a day during seven days after surgical treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * head and neck cancer with primary surgical treatment, enteral nutrition by enteral tube. Exclusion Criteria: * three months antibiotic use earlier the surgery, recently radiotherapy or quimiotherapy, inflammatory bowel disease.

Locations (1)

UFMG Hospital

Belo Horizonte, Minas Gerais, Brazil

Outcomes

Primary Outcomes

Serum DAO Enzyme Concentration

The intestinal permeability using serum DAO enzyme concentration (ng/mL) was determined by sandwich enzyme-linked immunosorbent assay (ELISA) kit (SEA656Hu), according to Cloud-Clone Corporation® (Huston, TX) specifications.

Time frame: 7 days

Secondary Outcomes

Infection Rate

According to Dindo et al, 2004

Time frame: 7 days

Data from ClinicalTrials.gov

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