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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Dietary Supplement: Lactobacillus plantarum 299v
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, home enteral nutrition, probiotic, Lactobacillus plantarum 299v