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
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Synbiotics Nutrition Therapy||Dietary Supplement: Symbiotic Dietary Supplement: Maltodextrin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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|
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
- 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.
- Infection Rate [ Time Frame: 7 days ]According to Dindo et al, 2004
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
|Belo horizonte, Minas Gerais, Brazil, 30640100|
|Principal Investigator:||Priscilla C Lages, bachelor||Federal University of Minas Gerais|