Trials / Completed
CompletedNCT03940768
The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Medical University of Gdansk · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-05-10
- Primary completion
- 2020-03-01
- Completion
- 2020-03-01
- First posted
- 2019-05-07
- Last updated
- 2020-03-30
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT03940768. Inclusion in this directory is not an endorsement.