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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Dietary supplement: Lactobacillus plantarum 299v; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland
    • Nutritional Counselling Centre Copernicus in Gdansk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus plantarum 299v receivers; Sanprobi IBS (Lactobacillus plantarum 299v) 2 capsules per day for 4 weeks.	Dietary supplement: Lactobacillus plantarum 299v; Administration of Lactobacillus plantarum 299v in cancer patients who receive home enteral nutrition.; Dietary supplement: Placebo; Administration of placebo in cancer patients who receive home enteral nutrition.
Placebo Comparator: Placebo receivers; Sanprobi IBS placebo 2 capsules per day for 4 weeks.	Dietary supplement: Lactobacillus plantarum 299v; Administration of Lactobacillus plantarum 299v in cancer patients who receive home enteral nutrition.; Dietary supplement: Placebo; Administration of placebo in cancer patients who receive home enteral nutrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of fat mass	fat mass in percent (%)	at baseline and after 4th week
Changes of muscle mass	muscle mass in kilograms (kg)	at baseline and after 4th week
Changes of total body water	total body water in percent (%)	at baseline and after 4th week
Changes of body mass index	body mass index in kg/m^2	at baseline and after 4th week
Changes of the albumin concentration	albumin concentration g/L	at baseline and after 4th week
Changes of total protein concentration	total protein concentration g/L	at baseline and after 4th week
Changes of total lymphocyte count	number of total lymphocyte count/mm^3	at baseline and after 4th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medical University of Gdansk

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: cancer; probiotic; Lactobacillus plantarum 299v; home enteral nutrition
• Other Study ID Numbers: MUGdansk1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No