L. Plantarum 299v and Gut Microbiome, Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients

August 24, 2023 updated by: Medical University of Gdansk

The Impact of Lactobacillus Plantarum 299v in Combination With Inulin on Gut Microbiome, Chemotherapy and Radiotherapy-induced Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients in Periooperative Period

Colorectal cancer in periooperative period patients (n=60) will be enrolled to this study. Participants will be divided into 4 groups as follows:

  • group 1 (n=15) will receive 2 capsules (per day) of L. plantarum 299v L. plantarum 299v (Sanprobi IBS®) for 4 weeks
  • group 2 (n=15) will receive L. plantarum 299v (2 capsules per day) and inulin (4 g) for 4 weeks
  • group 3 (n=15) will receive placebo (2 capsules per day) and inulin (4 g) for 4 weeks
  • group 4 (n=15) will receive placebo (2 capsules per day) for 4 weeks

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Kościerzyna, Poland, 83-400
        • Recruiting
        • Unit of Surgery with Unit of Oncological Surgery in Koscierzyna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age ≥18 oraz ≤65
  • patients with colorectal cancer prior to surgical treatment
  • qualification to surgery
  • the treatment with chemotherapy and radiotherapy in preoperative period
  • an appropriate swallowing
  • patients agreement to take part in this study

Exclusion Criteria:

  • the presence of other cancers than colorectal cancer
  • inflammatory bowel diseases
  • dysphagia
  • intake of antibiotics, proton pump inhibitors, probiotics, and synbiotics 3 months befor taking part in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lactobacillus plantarum 299v
15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks
Dietary supplement: Sanprobi IBS®
Patients will be treated with probiotics in combination with inulin, which is able to stimulate the growing of probiotic bacteria in gastrointestinal tract.
Experimental: Lactobacillus plantarum 299v in combination with inulin
15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v and inulin (4 g) for 4 weeks
Dietary supplement: Sanprobi IBS®
Patients will be treated with probiotics in combination with inulin, which is able to stimulate the growing of probiotic bacteria in gastrointestinal tract.
No Intervention: Placebo in combination with inulin
15 patients will receive 2 capsules (per day) of placebo and inulin (4 g) for 4 weeks
No Intervention: Placebo
15 patients will receive 2 capsules (per day) of placebo for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gut microbiota composition
Time Frame: 4 weeks
It will be measured by presenting alpha diversity and beta-diversity of microbial community and after that it will be presented using bioinformatic analysis.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chemotherapy and radiotherapy-induced diarrhoea
Time Frame: 4 weeks
It will be analysed by using own created survey.
4 weeks
Clostridioides difficile infection
Time Frame: 6 months
The incidence of Clostridioides difficile infection will be noted.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUGdansk_Lp299v

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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