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NCT02654652 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02654652
Other study ID # CAAE 24375713.0.0000.5149
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date July 2016

Study information
Verified date February 2019
Source Federal University of Minas Gerais
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date July 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Symbiotic
Intervention will consist of the adminitration of symbiotic product twice a day during seven days after surgical treatment
• Maltodextrin
Intervention will consist of the adminitration of placebo product twice a day during seven days after surgical treatment

Locations
Country Name City State
Brazil UFMG Hospital Belo horizonte Minas Gerais

Sponsors (1)
Lead Sponsor Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 7 days
Secondary Infection Rate According to Dindo et al, 2004 7 days
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