Clinical trial NCT03940768: The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition
Official title: The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer
home enteral nutrition
probiotic
Lactobacillus plantarum 299v
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the impact of Lactobacillus plantarum 299v on nutritional status, tolerance of enteral diet and the quality of life. Administration of this probiotic may potentially improve nutritional status and tolerance of enteral diet. It also may provide positive effect on quality of life.

Detailed description: Study group consists of patients with cancer who are qualified for home enteral nutrition in Nutritional Counselling Center Copernicus in Gdansk. The control group will receive home enteral nutrition and placebo. The experimental group will receive home enteral nutrition and Lactobacillus plantarum 299v. The study is prospective and double-blind. The parameters for evaluation of nutritional status are: BMI, body mass analysis, level of total protein and albumin in blood serum, total lymphocyte count, NRS 2002 method. Assessment of the quality of life and tolerance of enteral diet will be done by questionaires.

Eligibility criteria: Inclusion Criteria:

* age ≥18 yr.,
* the presence of cancer, artificial access to the alimentary tract (naso-gastric tube, gastrostomy, percutaneous endoscopic gastrostomy, jejunostomy, microjejunostomy),
* qualification for home enteral nutrition,
* written consent to take part in the study

Exclusion Criteria:

* age \<18 yr.,
* patients requiring home parenteral nutrition,
* patients who are not being able to attend the visit in the study centre.

Primary outcomes:
measure: Changes of fat mass
timeFrame: at baseline and after 4th week
measure: Changes of muscle mass
timeFrame: at baseline and after 4th week
measure: Changes of total body water
timeFrame: at baseline and after 4th week
measure: Changes of body mass index
timeFrame: at baseline and after 4th week
measure: Changes of the albumin concentration
timeFrame: at baseline and after 4th week
measure: Changes of total protein concentration
timeFrame: at baseline and after 4th week
measure: Changes of total lymphocyte count
timeFrame: at baseline and after 4th week
Secondary outcomes:
measure: Change of enteral nutrition tolerance
timeFrame: it will be filled every day by patients per 4 weeks treatment period
measure: Change of patients' quality of life ( BREF - WHOQOL - Bref The World Health Organization Quality of Life)
timeFrame: at baseline and after 4th week
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Nutritional Counselling Centre Copernicus in Gdansk
Study officials:
References:
citation: Kazmierczak-Siedlecka K, Folwarski M, Skonieczna-Zydecka K, Ruszkowski J, Makarewicz W. The use of Lactobacillus plantarum 299v (DSM 9843) in cancer patients receiving home enteral nutrition - study protocol for a randomized, double-blind, and placebo-controlled trial. Nutr J. 2020 Sep 11;19(1):98. doi: 10.1186/s12937-020-00598-w.