NCT06019312

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

August 10, 2023

Last Update Submit

August 24, 2023

Conditions

Colorectal CancerClostridioides Difficile InfectionDiarrhea

Keywords

Lactobacillus plantarum 299vProbioticsColorectal CancerClostridioides difficileDiarrhea

Outcome Measures

Primary Outcomes (1)

  • gut microbiota composition

    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 Outcomes (2)

  • chemotherapy and radiotherapy-induced diarrhoea

    4 weeks

  • Clostridioides difficile infection

    6 months

Study Arms (4)

Lactobacillus plantarum 299v

EXPERIMENTAL

15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks

Dietary Supplement: Sanprobi IBS®

Lactobacillus plantarum 299v in combination with inulin

EXPERIMENTAL

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®

Placebo in combination with inulin

NO INTERVENTION

15 patients will receive 2 capsules (per day) of placebo and inulin (4 g) for 4 weeks

Placebo

NO INTERVENTION

15 patients will receive 2 capsules (per day) of placebo for 4 weeks

Interventions

Sanprobi IBS®DIETARY_SUPPLEMENT

Patients will be treated with probiotics in combination with inulin, which is able to stimulate the growing of probiotic bacteria in gastrointestinal tract.

Lactobacillus plantarum 299vLactobacillus plantarum 299v in combination with inulin

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Surgery with Unit of Oncological Surgery in Koscierzyna

Kościerzyna, 83-400, Poland

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsClostridium InfectionsDiarrhea

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Karolina Kaźmierczak-Siedlecka, PhD

CONTACT

607507240leokadia@gumed.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 31, 2023

Study Start

August 1, 2023

Primary Completion

May 30, 2024

Study Completion

June 1, 2024

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations

PL(1)