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CancerNCT03940768

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

A study testing Lactobacillus plantarum 299v in people with Cancer, run by Medical University of Gdansk at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Lactobacillus plantarum 299v
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
1 sitePoland
Study dates
10 May 2019to 1 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • age <18 yr.,
  • patients requiring home parenteral nutrition,
  • patients who are not being able to attend the visit in the study centre.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Nutritional Counselling Centre Copernicus in Gdansk

    Gdansk

Other trials in Poland

About this study

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.

Read the 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
Cancer
Being tested
Lactobacillus plantarum 299v, Placebo
Keywords
cancer, home enteral nutrition, probiotic, Lactobacillus plantarum 299v
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactobacillus plantarum 299vDietary supplement

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

  • PlaceboDietary supplement

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

Study groups in NCT03940768
Study groupRoleWhat they receive
Lactobacillus plantarum 299v receiversExperimentalSanprobi IBS (Lactobacillus plantarum 299v) 2 capsules per day for 4 weeks.
Receives: Dietary Supplement: Lactobacillus plantarum 299v; Dietary Supplement: Placebo
Placebo receiversPlacebo comparatorSanprobi IBS placebo 2 capsules per day for 4 weeks.
Receives: Dietary Supplement: Lactobacillus plantarum 299v; Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of fat mass

    fat mass in percent (%)

    Measured: at baseline and after 4th week

  2. Changes of muscle mass

    muscle mass in kilograms (kg)

    Measured: at baseline and after 4th week

  3. Changes of total body water

    total body water in percent (%)

    Measured: at baseline and after 4th week

  4. Changes of body mass index

    body mass index in kg/m^2

    Measured: at baseline and after 4th week

  5. Changes of the albumin concentration

    albumin concentration g/L

    Measured: at baseline and after 4th week

  6. Changes of total protein concentration

    total protein concentration g/L

    Measured: at baseline and after 4th week

  7. Changes of total lymphocyte count

    number of total lymphocyte count/mm^3

    Measured: at baseline and after 4th week

Secondary outcomes (2)

  1. Change of enteral nutrition tolerance

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

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

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

    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.

    Measured: at baseline and after 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2019
  2. Study start10 May 2019
  3. Primary completion1 Mar 2020
  4. Study completion1 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03940768
Sponsor's protocol ID
MUGdansk1
Status last verified
Mar 2020
First submitted
31 Jan 2019
Last updated
30 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kazmierczak-Siedlecka K, Folwarski M, Skonieczna-Zydecka K, Ruszkowski J, Makarewicz W. The use of Lactobacillus plantarum 299v (DSM 9843) in cancer patients receiving home enteral nutrition - study protocol for a randomized, double-blind, and placebo-controlled trial. Nutr J. 2020 Sep 11;19(1):98. doi: 10.1186/s12937-020-00598-w.

    PubMed 32917221

Questions about this trial

What is this clinical trial studying?

A study testing Lactobacillus plantarum 299v in people with Cancer, run by Medical University of Gdansk at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of fat mass (time frame: at baseline and after 4th week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03940768, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.

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