Intestinal Function of Patients With Uper Air and Digestive Neoplasia Submitted to Surgical Treatment: Symbiotic Use Impact
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Serum DAO Enzyme Concentration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Symbiotic (Dietary Supplement)
Maltodextrin
Patients will receive 6g of maltodextrin twice a day during seven days after surgical treatment.
Intervention: Maltodextrin (Dietary Supplement)
Outcomes
Primary Outcomes
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 Outcomes
- Infection Rate(7 days)
Investigators
Maria Isabel Toulson Davisson Correia
PhD
Federal University of Minas Gerais