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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03940768

Recruitment Status Completed

First Posted May 7, 2019

Last update posted March 30, 2020

Study Description

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:Cancer
  • Intervention/Treatment: Dietary Supplement: Lactobacillus plantarum 299v
    Dietary Supplement: Placebo
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • 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 2019
  • Actual Primary Completion Date: March 2020
  • Actual Study Completion Date: March 2020
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 1. Changes of body mass index [ Time Frame: at baseline and after 4th week ]
    body mass index in kg/m^2
  • 2. Changes of the albumin concentration [ Time Frame: at baseline and after 4th week ]
    albumin concentration g/L
  • 3. Changes of total protein concentration [ Time Frame: at baseline and after 4th week ]
    total protein concentration g/L
  • 4. Changes of fat mass [ Time Frame: at baseline and after 4th week ]
    fat mass in percent (%)
  • 5. Changes of muscle mass [ Time Frame: at baseline and after 4th week ]
    muscle mass in kilograms (kg)
  • 6. Changes of total body water [ Time Frame: at baseline and after 4th week ]
    total body water in percent (%)
  • 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.
Eligibility Criteria
  • 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.

Contacts and Locations
Contacts
Locations

Poland
Nutritional Counselling Centre Copernicus in Gdansk
Gdańsk

Sponsors and Collaborators

Medical University of Gdansk

More Information
  • Responsible Party: Medical University of Gdansk
  • ClinicalTrials.gov Identifier: NCT03940768 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Medical University of Gdansk: cancer
    home enteral nutrition
    probiotic
    Lactobacillus plantarum 299v