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

Primary Purpose

Head and Neck Cancer, Synbiotics, Nutrition Therapy

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Symbiotic

Maltodextrin

About this trial

This is an interventional supportive care trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UFMG Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Symbiotic

Maltodextrin

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Serum DAO Enzyme Concentration

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

Infection Rate

According to Dindo et al, 2004

Full Information

NCT ID

NCT02654652

First Posted

January 7, 2016

Last Updated

February 27, 2019

Sponsor

Federal University of Minas Gerais

1. Study Identification

Unique Protocol Identification Number

NCT02654652

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer, Synbiotics, Nutrition Therapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Symbiotic

Arm Type

Experimental

Arm Description

Arm Title

Maltodextrin

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Symbiotic

Other Intervention Name(s)

LactoFos

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Maltodextrin

Intervention Description

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

Primary Outcome Measure Information:

Title

Serum DAO Enzyme Concentration

Description

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Infection Rate

Description

According to Dindo et al, 2004

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Priscilla C Lages, bachelor

Organizational Affiliation

Federal University of Minas Gerais

Official's Role

Principal Investigator

Facility Information:

Facility Name

UFMG Hospital

City

Belo horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30640100

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

18702178

Citation

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.

Results Reference

result

PubMed Identifier

29277158

Citation

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.

Results Reference

derived

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

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