Clostridium difficile infection
Conditions
Interventions
Product Name: Bifidobacterium infantis 35624
Product Code: Bifidobacterium infantis 35624
Pharmaceutical Form: Oral suspension
Other descriptive name: Bifidobacteria infantis 35624
Concentration uni
Sponsors
Alimentary Health Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be considered eligible for enrolment into the study, subjects must 1. Be greater than 50 years of age, 2. Be in generally good health as determined by the investigator Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if they meet any of the below criteria; 1. Are less than 50 years of age 2. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, immunological) or a condition which contraindicates, in the investigators judgement, entry to the study. 3. Prior gastrointestinal surgery (apart from appendicectomy and hernia repair) or recent unexplained bleeding which, in the Investigator’s judgment, contraindicates participation in the study. 4. Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results. 5. Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial. 6. Patients may not be receiving treatment involving experimental drugs. 7. If the patient has been in a recent experimental trial, must be not less than 30 days prior to this study. 8. Have a malignant disease or any concomitant end-stage organ disease, which, in the Investigator’s judgment, contraindicates participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ·To define the prevalence of Clostridium difficile carriage in hospitalized patients greater the 50 years of age including patients in long-term care settings ·To establish whether the consumption of probiotic strain Bifidobacterium infantis 35624 affects the carriage rate and clinical history of Clostridium difficile disease. ;Secondary Objective: ;Primary end point(s): -To define the prevalence of Clostridium difficile carriage in hospitalized patients greater the 50 years of age including patients in long-term care settings -To establish whether the consumption of probiotic strain Bifidobacterium infantis 35624 affects the carriage rate and clinical history of Clostridium difficile disease. | — |
Countries
Ireland
Outcome results
None listed