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Trial record 2 of 6 for:    lactobacillus plantarum 299v

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03940768
Recruitment Status : Completed
First Posted : May 7, 2019
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Karolina Kaźmierczak-Siedlecka, Medical University of Gdansk

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.

Condition or disease Intervention/treatment Phase
Cancer Dietary Supplement: Lactobacillus plantarum 299v Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition
Actual Study Start Date : May 10, 2019
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940768


Locations
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Poland
Nutritional Counselling Centre Copernicus in Gdansk
Gdańsk, Poland
Sponsors and Collaborators
Medical University of Gdansk
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karolina Kaźmierczak-Siedlecka, Karolina Kaźmierczak-Siedlecka (nutritionist, PhD student - Department of Surgical Oncology), Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT03940768    
Other Study ID Numbers: MUGdansk1
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karolina Kaźmierczak-Siedlecka, Medical University of Gdansk:
cancer
home enteral nutrition
probiotic
Lactobacillus plantarum 299v