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

NCT ID: NCT06019312

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-06-01

Brief Summary

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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

Detailed Description

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Conditions

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Colorectal Cancer Clostridioides Difficile Infection Diarrhea

Keywords

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Lactobacillus plantarum 299v Probiotics Colorectal Cancer Clostridioides difficile Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lactobacillus plantarum 299v

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

Group Type EXPERIMENTAL

Sanprobi IBS®

Intervention Type 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 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

Group Type EXPERIMENTAL

Sanprobi IBS®

Intervention Type 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.

Placebo in combination with inulin

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Placebo

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Unit of Surgery with Unit of Oncological Surgery in Koscierzyna

Kościerzyna, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Karolina Kaźmierczak-Siedlecka, PhD

Role: CONTACT

Phone: 607507240

Email: [email protected]

Facility Contacts

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Paweł Ulasiński

Role: primary

Other Identifiers

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MUGdansk_Lp299v

Identifier Type: -

Identifier Source: org_study_id