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

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Nutrition Therapy; Synbiotics
• Interventions: Dietary Supplement: Symbiotic; Dietary Supplement: Maltodextrin

• Registration Number: NCT02654652
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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.

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 Timeline

• Study Start: 2014-10
• Primary Completion: 2016-01
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-13
• Study Completion: 2016-07
• Results First Submitted: 2016-11-14
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-27
• Last Update Submitted: 2019-02-27
• Results First Posted: 2019-06-05
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symbiotic	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.
Maltodextrin	Maltodextrin	Patients will receive 6g of maltodextrin twice a day during seven days after surgical treatment.

Primary Outcome Measures

Name	Time	Method
Serum DAO Enzyme Concentration	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 Outcome Measures

Name	Time	Method
Infection Rate	7 days	According to Dindo et al, 2004

Trial Locations

Locations (1)

UFMG Hospital; 🇧🇷 Belo horizonte, Minas Gerais, Brazil