Clostridioides Difficile InfectionNCT06859437
Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department
A study testing Prevention of C. difficile infections using LP299v strain LP299v in people with Clostridioides Difficile Infection, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The aim of this study was to analyze whether the use of the LP299v strain reduces the risk of Clostridium difficile infection (CDI) among patients receiving antibiotics and hospitalized in the nephrology and transplantation ward. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridioides Difficile Infection
- What is being tested?
- Prevention of C. difficile infections using LP299v strain LP299v
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years old
- organ transplantation or receiving immunosuppressive drugs for any other reasons
- antibiotics therapy
Who cannot join
- no consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Nephrology, Transplantation and Intenal Medicine Medical University of Silesia
Poland, Silesian Voivodeship, 40-027
About this study
The aim of this study was to analyze whether the use of the LP299v strain reduces the risk of Clostridium difficile infection (CDI) among patients receiving antibiotics and hospitalized in the nephrology and transplantation ward.
Adutt patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study.
Read more
Patients who meet the above criteria for inclusion in the study will be assigned to one of two groups. Patients in group I (study) will receive a probiotic containing the Lactobacillus plantarum 299v strain of bacteria as part of the prophylaxis of Clostridioides difficile infection. The daily dose is 1 capsule containing approximately 10x109 colony-forming units of live bacteria taken orally with a meal. Patients in group II (control) will receive a placebo. The duration of probiotic or placebo use will be 3 months. Assignment to groups I and II will be random. The number of patients in each group will be 150.
Participants will be divided into two groups. First group will receive one capsule of Lactobacillus plantarum 299v (LP299v) orally per a day. Second group will receive placebo. The observation period will last 3 months. The evaluation will consist of an interview, physical examination and laboratory tests.
Read the detailed description
The study is prospective. It will include 300 patients undergoing antibiotic therapy. The duration of the study is estimated at 36 months (from 01.10.2024 to 31.10.2027).
The study will be conducted among patients hospitalized in the Clinic of Nephrology, Transplantology and Internal Medicine of the Medical University of Silesia/Department of Nephrology, Transplantology and Internal Medicine of the Independent Public Clinical Hospital named after Andrzej Mielęcki of the Medical University of Silesia in Katowice. The study will include patients undergoing immunosuppressive treatment undergoing antibiotic therapy. The exclusion criterion from the study is the lack of consent of the patient to participate in the study.The aim of this study was to analyze whether the use of the LP299v strain reduces the risk of Clostridium difficile infection (CDI) among patients receiving antibiotics and hospitalized in the nephrology and transplantation ward.
Adutt patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study.
Patients who meet the above criteria for inclusion in the study will be assigned to one of two groups. Patients in group I (study) will receive a probiotic containing the Lactobacillus plantarum 299v strain of bacteria as part of the prophylaxis of Clostridioides difficile infection. The daily dose is 1 capsule containing approximately 10x109 colony-forming units of live bacteria taken orally with a meal. Patients in group II (control) will receive a placebo. The duration of probiotic or placebo use will be 3 months. Assignment to groups I and II will be random. The number of patients in each group will be 150.
Participants will be divided into two groups. First group will receive one capsule of Lactobacillus plantarum 299v (LP299v) orally per a day. Second group will receive placebo. The observation period will last 3 months. The evaluation will consist of an interview, physical examination and laboratory tests.
The patient interview will include, among others:
- assessment of gastrointestinal complaints
- assessment of the number of stools per day and their consistency
- incidence of CDI
- incidence of other infectious diseases
The following laboratory and microbiological tests are planned for all patients in the randomized study:
- microbiological assessment of stool before starting treatment
- measurement of C-reactive protein, interleukin 6 and lipopolysaccharide LPS concentration in blood serum and assessment of peripheral blood morphology before starting treatment, on the 7th day of treatment and after 1 month.
- blood culture on MRS Agar before starting treatment, on the 8th-10th day of treatment and after 1 month After 3 months, a telephone interview with the patient is planned to collect information about the occurrence of diarrhea or other gastrointestinal disorders, Clostridioides difficile infection or other infectious diseases in the period of 3 months from the start of probiotic or placebo use.
- Conditions
- Clostridioides Difficile Infection
- Being tested
- Prevention of C. difficile infections using LP299v strain Placebo, Prevention of C. difficile infections using LP299v strain LP299v
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention of C. difficile infections using LP299v strain PlaceboDietary supplement
Patients treated with antibiotics and at high CDI risk (patients after organ transplantation or receiving immunosuppressive therapy for any other reason) will be enroll to study.
One capsule of placebo orally per a day during the entire period of antibiotic therapy.
Prevention of C. difficile infections using LP299v strain LP299vDietary supplement
Patients treated with antibiotics and at high CDI risk (patients after organ transplantation or receiving immunosuppressive therapy for any other reason) will be enroll to study.
One capsule of LP299v orally per a day during the entire period of antibiotic therapy.
| Study group | Role | What they receive |
|---|---|---|
| LP299v group | Experimental | Participants: one capsule of LP299v orally per a day during the entire period of antibiotic therapy. Receives: Dietary Supplement: Prevention of C. difficile infections using LP299v strain LP299v |
| Placebo group | Placebo comparator | Participants: one capsule of placebo orally per a day during the entire period of antibiotic therapy. Receives: Dietary Supplement: Prevention of C. difficile infections using LP299v strain Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clostridium difficile infection
Measured: Three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Oct 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile InfectionStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859437
- Sponsor's protocol ID
- SilesianMUKB1/78/24
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department
- ClinicalTrials.gov ID
- NCT06859437
- Acronym / sponsor ID
- SilesianMUKB1/78/24
- Conditions
- Clostridioides Difficile Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 5 Mar 2025 (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.
The aim of this study was to analyze whether the use of the LP299v strain reduces the risk of Clostridium difficile infection (CDI) among patients receiving antibiotics and hospitalized in the nephrology and transplantation ward.
Adutt patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study.
Patients who meet the above criteria for inclusion in the study will be assigned to one of two groups. Patients in group I (study) will receive a probiotic containing the Lactobacillus plantarum 299v strain of bacteria as part of the prophylaxis of Clostridioides difficile infection. The daily dose is 1 capsule containing approximately 10x109 colony-forming units of live bacteria taken orally with a meal. Patients in group II (control) will receive a placebo. The duration of probiotic or placebo use will be 3 months. Assignment to groups I and II will be random. The number of patients in each group will be 150.
Participants will be divided into two groups. First group will receive one capsule of Lactobacillus plantarum 299v (LP299v) orally per a day. Second group will receive placebo. The observation period will last 3 months. The evaluation will consist of an interview, physical examination and laboratory tests.
Detailed description
The study is prospective. It will include 300 patients undergoing antibiotic therapy. The duration of the study is estimated at 36 months (from 01.10.2024 to 31.10.2027).
The study will be conducted among patients hospitalized in the Clinic of Nephrology, Transplantology and Internal Medicine of the Medical University of Silesia/Department of Nephrology, Transplantology and Internal Medicine of the Independent Public Clinical Hospital named after Andrzej Mielęcki of the Medical University of Silesia in Katowice. The study will include patients undergoing immunosuppressive treatment undergoing antibiotic therapy. The exclusion criterion from the study is the lack of consent of the patient to participate in the study.The aim of this study was to analyze whether the use of the LP299v strain reduces the risk of Clostridium difficile infection (CDI) among patients receiving antibiotics and hospitalized in the nephrology and transplantation ward.
Adutt patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study.
Patients who meet the above criteria for inclusion in the study will be assigned to one of two groups. Patients in group I (study) will receive a probiotic containing the Lactobacillus plantarum 299v strain of bacteria as part of the prophylaxis of Clostridioides difficile infection. The daily dose is 1 capsule containing approximately 10x109 colony-forming units of live bacteria taken orally with a meal. Patients in group II (control) will receive a placebo. The duration of probiotic or placebo use will be 3 months. Assignment to groups I and II will be random. The number of patients in each group will be 150.
Participants will be divided into two groups. First group will receive one capsule of Lactobacillus plantarum 299v (LP299v) orally per a day. Second group will receive placebo. The observation period will last 3 months. The evaluation will consist of an interview, physical examination and laboratory tests.
The patient interview will include, among others:
- assessment of gastrointestinal complaints
- assessment of the number of stools per day and their consistency
- incidence of CDI
- incidence of other infectious diseases
The following laboratory and microbiological tests are planned for all patients in the randomized study:
- microbiological assessment of stool before starting treatment
- measurement of C-reactive protein, interleukin 6 and lipopolysaccharide LPS concentration in blood serum and assessment of peripheral blood morphology before starting treatment, on the 7th day of treatment and after 1 month.
- blood culture on MRS Agar before starting treatment, on the 8th-10th day of treatment and after 1 month After 3 months, a telephone interview with the patient is planned to collect information about the occurrence of diarrhea or other gastrointestinal disorders, Clostridioides difficile infection or other infectious diseases in the period of 3 months from the start of probiotic or placebo use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LP299v group | Experimental | Dietary Supplement: Prevention of C. difficile infections using LP299v strain LP299vParticipants: one capsule of LP299v orally per a day during the entire period of antibiotic therapy. |
| Placebo group | Placebo comparator | Dietary Supplement: Prevention of C. difficile infections using LP299v strain PlaceboParticipants: one capsule of placebo orally per a day during the entire period of antibiotic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 18 years old
- organ transplantation or receiving immunosuppressive drugs for any other reasons
- antibiotics therapy
Key exclusion criteria (1 listed)
- no consent to participate in the 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 |
|---|---|---|
| Prevention of C. difficile infections using LP299v strain PlaceboPatients treated with antibiotics and at high CDI risk (patients after organ transplantation or receiving immunosuppressive therapy for any other reason) will be enroll to study. One capsule of placebo orally per a day during the entire period of antibiotic therapy. | Dietary supplement | Placebo group |
| Prevention of C. difficile infections using LP299v strain LP299vPatients treated with antibiotics and at high CDI risk (patients after organ transplantation or receiving immunosuppressive therapy for any other reason) will be enroll to study. One capsule of LP299v orally per a day during the entire period of antibiotic therapy. | Dietary supplement | LP299v group |
Primary outcome
Clostridium difficile infection
Time frame: Three month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Clostridioides Difficile Infection
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Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
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C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention of C. difficile infections using LP299v strain LP299v in people with Clostridioides Difficile Infection, run by Medical University of Silesia 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylwia Dudzicz-Gojowy, PhD, MD (+48322591432, sdudzicz@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clostridium difficile infection (time frame: Three month). 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 5 Mar 2025.