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

Federal University of Minas Gerais

Status: Completed

Conditions: Nutrition Therapy; Head and Neck Cancer; Synbiotics

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Symbiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT02654652

CAAE 24375713.0.0000.5149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

Symbiotic

Experimental group

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.

Treatment:

Dietary Supplement: Symbiotic

Maltodextrin

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Maltodextrin