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

NCT ID: NCT02654652

Last Updated: 2019-06-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer Synbiotics Nutrition Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Symbiotic

Intervention Type DIETARY_SUPPLEMENT

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

Maltodextrin

Patients will receive 6g of maltodextrin twice a day during seven days after surgical treatment.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Symbiotic

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

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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LactoFos

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Maria Isabel Toulson Davisson Correia

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Priscilla C Lages, bachelor

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

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UFMG Hospital

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? 1987. Classical article. Nutr Hosp. 2008 Jul-Aug;23(4):400-7. No abstract available.

Reference Type RESULT
PMID: 18702178 (View on PubMed)

Lages PC, Generoso SV, Correia MITD. Postoperative symbiotic in patients with head and neck cancer: a double-blind randomised trial. Br J Nutr. 2018 Jan;119(2):190-195. doi: 10.1017/S0007114517003403. Epub 2017 Dec 26.

Reference Type DERIVED
PMID: 29277158 (View on PubMed)

Other Identifiers

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CAAE 24375713.0.0000.5149

Identifier Type: -

Identifier Source: org_study_id

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