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

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ClinicalTrials.gov Identifier: NCT02654652
Recruitment Status : Completed
First Posted : January 13, 2016
Results First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Synbiotics Nutrition Therapy Dietary Supplement: Symbiotic Dietary Supplement: Maltodextrin Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Intestinal Function of Patients With Uper Air and Digestive Neoplasia Submitted to Surgical Treatment: Symbiotic Use Impact
Study Start Date : October 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : July 2016
Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Infection Rate [ Time Frame: 7 days ]
    According to Dindo et al, 2004


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654652


Locations
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Brazil
UFMG Hospital
Belo horizonte, Minas Gerais, Brazil, 30640100
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
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Principal Investigator: Priscilla C Lages, bachelor Federal University of Minas Gerais
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maria Isabel Toulson Davisson Correia, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02654652     History of Changes
Other Study ID Numbers: CAAE 24375713.0.0000.5149
First Posted: January 13, 2016    Key Record Dates
Results First Posted: June 5, 2019
Last Update Posted: June 5, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms