NCT03940768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

January 31, 2019

Last Update Submit

March 27, 2020

Conditions

Cancer

Keywords

cancerhome enteral nutritionprobioticLactobacillus plantarum 299v

Outcome Measures

Primary Outcomes (7)

  • Changes of fat mass

    fat mass in percent (%)

    at baseline and after 4th week

  • Changes of muscle mass

    muscle mass in kilograms (kg)

    at baseline and after 4th week

  • Changes of total body water

    total body water in percent (%)

    at baseline and after 4th week

  • Changes of body mass index

    body mass index in kg/m\^2

    at baseline and after 4th week

  • Changes of the albumin concentration

    albumin concentration g/L

    at baseline and after 4th week

  • Changes of total protein concentration

    total protein concentration g/L

    at baseline and after 4th week

  • Changes of total lymphocyte count

    number of total lymphocyte count/mm\^3

    at baseline and after 4th week

Secondary Outcomes (2)

  • Change of enteral nutrition tolerance

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

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

    at baseline and after 4th week

Study Arms (2)

Lactobacillus plantarum 299v receivers

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus plantarum 299vDietary Supplement: Placebo

Placebo receivers

PLACEBO COMPARATOR

Sanprobi IBS placebo 2 capsules per day for 4 weeks.

Dietary Supplement: Lactobacillus plantarum 299vDietary Supplement: Placebo

Interventions

Lactobacillus plantarum 299vDIETARY_SUPPLEMENT

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

Lactobacillus plantarum 299v receiversPlacebo receivers
PlaceboDIETARY_SUPPLEMENT

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

Lactobacillus plantarum 299v receiversPlacebo receivers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutritional Counselling Centre Copernicus in Gdansk

Gdansk, Poland

Location

Related Publications (1)

  • 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.

    PMID: 32917221DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Karolina Kaźmierczak-Siedlecka (nutritionist, PhD student - Department of Surgical Oncology)

Study Record Dates

First Submitted

January 31, 2019

First Posted

May 7, 2019

Study Start

May 10, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)