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

Medical University of Gdansk

Status: Completed

Conditions: Cancer

Treatments: Dietary Supplement: Lactobacillus plantarum 299v; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03940768

MUGdansk1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

Lactobacillus plantarum 299v receivers

Experimental group

Description:

Sanprobi IBS (Lactobacillus plantarum 299v) 2 capsules per day for 4 weeks.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Lactobacillus plantarum 299v

Placebo receivers

Placebo Comparator group

Description:

Sanprobi IBS placebo 2 capsules per day for 4 weeks.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Lactobacillus plantarum 299v