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

February 27, 2019 updated by: Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais

Intestinal Function of Patients With Uper Air and Digestive Neoplasia Submitted to Surgical Treatment: Symbiotic Use Impact

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo horizonte, Minas Gerais, Brazil, 30640100
        • UFMG Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symbiotic
Patients will receive the symbiotic product LactoFos twice a day during seven days after surgical treatment. The intervention consists of giving twice a day a sachet of 6g of symbiotic diluted in 20mL of water via nasoenteric tube for seven days, totaling the administration of 14 sachets per intervention.
Dietary supplement: Symbiotic
Intervention will consist of the adminitration of symbiotic product twice a day during seven days after surgical treatment
Other Names:
  • LactoFos
Placebo Comparator: Maltodextrin
Patients will receive 6g of maltodextrin twice a day during seven days after surgical treatment.
Dietary supplement: Maltodextrin
Intervention will consist of the adminitration of placebo product twice a day during seven days after surgical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum DAO Enzyme Concentration
Time Frame: 7 days
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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection Rate
Time Frame: 7 days
According to Dindo et al, 2004
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Investigators

  • Principal Investigator: Priscilla C Lages, bachelor, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 24375713.0.0000.5149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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