Colorectal CancerNCT06019312
L. Plantarum 299v and Gut Microbiome, Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients
A study testing Sanprobi IBS® in people with Colorectal Cancer and Clostridioides Difficile Infection, run by Medical University of Gdansk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Cancer, Clostridioides Difficile Infection, Diarrhea
- What is being tested?
- Sanprobi IBS®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2023to 1 Jun 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Unit of Surgery with Unit of Oncological Surgery in Koscierzyna
Kościerzyna, 83-400
Paweł Ulasiński, 537168985, ulasinskipawel@gmail.com
About this study
Official title: 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
- Being tested
- Sanprobi IBS®
- Keywords
- Lactobacillus plantarum 299v, Probiotics, Colorectal Cancer, Clostridioides difficile, Diarrhea
- Medical subject headings
- Colorectal Neoplasms, Clostridium Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus plantarum 299v | Experimental | 15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
chemotherapy and radiotherapy-induced diarrhoea
It will be analysed by using own created survey.
Measured: 4 weeks
Clostridioides difficile infection
The incidence of Clostridioides difficile infection will be noted.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Aug 2023
- Primary completion30 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019312
- Sponsor's protocol ID
- MUGdansk_Lp299v
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06019312
- Acronym / sponsor ID
- MUGdansk_Lp299v
- Keywords
- Lactobacillus plantarum 299v, Probiotics, Colorectal Cancer, Clostridioides difficile, Diarrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus plantarum 299v | Experimental | Dietary Supplement: Sanprobi IBS®15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks |
| Lactobacillus plantarum 299v in combination with inulin | Experimental | Dietary Supplement: Sanprobi IBS®15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v and inulin (4 g) for 4 weeks |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Lactobacillus plantarum 299v, Lactobacillus plantarum 299v in combination with inulin |
Primary outcome
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.
2 secondary outcomes
chemotherapy and radiotherapy-induced diarrhoea
Time frame: 4 weeks
Clostridioides difficile infection
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sanprobi IBS® in people with Colorectal Cancer and Clostridioides Difficile Infection, 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karolina Kaźmierczak-Siedlecka, PhD (607507240, leokadia@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gut microbiota composition (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2023.