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Completed

NCT Number: NCT03940768

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutritional Counselling Centre Copernicus in Gdansk

Gdansk, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus plantarum 299v

Dietary Supplement

Administration of Lactobacillus plantarum 299v in cancer patients who receive home enteral nutrition.

Placebo

Dietary Supplement

Administration of placebo in cancer patients who receive home enteral nutrition.

Primary outcomes

  1. Changes of fat mass

    Time frame: at baseline and after 4th week

    fat mass in percent (%)

  2. Changes of muscle mass

    Time frame: at baseline and after 4th week

    muscle mass in kilograms (kg)

  3. Changes of total body water

    Time frame: at baseline and after 4th week

    total body water in percent (%)

  4. Changes of body mass index

    Time frame: at baseline and after 4th week

    body mass index in kg/m^2

  5. Changes of the albumin concentration

    Time frame: at baseline and after 4th week

    albumin concentration g/L

  6. Changes of total protein concentration

    Time frame: at baseline and after 4th week

    total protein concentration g/L

  7. Changes of total lymphocyte count

    Time frame: at baseline and after 4th week

    number of total lymphocyte count/mm^3

Secondary outcomes

  1. Change of enteral nutrition tolerance

    Time frame: it will be filled every day by patients per 4 weeks treatment period

    The enteral nutrition tolerance will be assessed with authors own questionnaire referring to number of stools, frequency of vomiting and flatulence.

  2. Change of patients' quality of life ( BREF - WHOQOL - Bref The World Health Organization Quality of Life)

    Time frame: at baseline and after 4th week

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 7, 2019
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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