Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain
1 other identifier
interventional
300
0 countries
N/A
Brief 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. Patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2017
CompletedFirst Posted
Study publicly available on registry
December 11, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedDecember 11, 2017
September 1, 2017
3 years
December 4, 2017
December 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clostridium difficile infection
During hospitalization - average of 14 days
Study Arms (2)
LP299v group
EXPERIMENTALParticipants: one capsule of LP299v orally per a day during the entire period of antibiotic therapy.
Placebo group
PLACEBO COMPARATORParticipants: one capsule of placebo orally per a day during the entire period of antibiotic therapy.
Interventions
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. We will divide participants into two group. Group 1 will receive one capsule of LP299v orally per a day during the entire period of antibiotic therapy. Group 2 will receive one capsule of placebo during the entire period of antibiotic therapy.
Eligibility Criteria
You may qualify if:
- over 18 years old
- organ transplantation or receiving immunosuppressive drugs for any other reasons
- antibiotics therapy
You may not qualify if:
- no consent to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2017
First Posted
December 11, 2017
Study Start
January 1, 2018
Primary Completion
January 1, 2021
Study Completion
July 1, 2021
Last Updated
December 11, 2017
Record last verified: 2017-09