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Completed

NCT Number: NCT02654652

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

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.

Completed

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Nutrition Therapy Synbiotics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UFMG Hospital

Belo Horizonte, Minas Gerais, 30640100, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symbiotic

Dietary Supplement

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

Other names: LactoFos

Maltodextrin

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Infection Rate

    Time frame: 7 days

    According to Dindo et al, 2004

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2016
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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