The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition

Cancer Clinical Trial

Official title:

The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940768
• Other study ID #: MUGdansk1
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Dietary Supplement:
• Lactobacillus plantarum 299v
Administration of Lactobacillus plantarum 299v in cancer patients who receive home enteral nutrition.
• Placebo
Administration of placebo in cancer patients who receive home enteral nutrition.

Locations

Country	Name	City	State
Poland	Nutritional Counselling Centre Copernicus in Gdansk	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of fat mass	fat mass in percent (%)	at baseline and after 4th week
Primary	Changes of muscle mass	muscle mass in kilograms (kg)	at baseline and after 4th week
Primary	Changes of total body water	total body water in percent (%)	at baseline and after 4th week
Primary	Changes of body mass index	body mass index in kg/m^2	at baseline and after 4th week
Primary	Changes of the albumin concentration	albumin concentration g/L	at baseline and after 4th week
Primary	Changes of total protein concentration	total protein concentration g/L	at baseline and after 4th week
Primary	Changes of total lymphocyte count	number of total lymphocyte count/mm^3	at baseline and after 4th week
Secondary	Change of enteral nutrition tolerance	The enteral nutrition tolerance will be assessed with authors own questionnaire referring to number of stools, frequency of vomiting and flatulence.	it will be filled every day by patients per 4 weeks treatment period
Secondary	Change of patients' quality of life ( BREF - WHOQOL - Bref The World Health Organization Quality of Life)	Questionare containing questions divided in 4 domains (regarding environment, psychological, somatic, social factors). Each question gets points in scale 1-5, where 1 being the worst score. Within each domain poins are summed up.	at baseline and after 4th week