The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile levels of elderly subjects.
The study objective is to evaluate the effect of a probiotic Lactobacillus strain in lowering the levels of Clostridium difficile in the intestine of elderly subjects. In addition, the nutritional and general health status will be assessed using validated health related questionnaires. Bowel function and prevalence of infections will be followed throughout the intervention period. The study population consists of elderly home inhabitants. The study will be conducted as a double-blind placebo-controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
104
4 month probiotic intervention with 1 month run-in and 1 month wash-out. Probiotic given once a day.
Elderly Home Kerttuli
Turku, Finland
Change in level of faecal Clostridium difficile
Quantification of C. difficile from faecal samples
Time frame: 0 weeks, 8 weeks, 16 weeks
Change in nutritional status
Evaluated according to the Mini Nutritional Assessment (MNA®) questionnaire.
Time frame: 0 weeks, 16 weeks
Change in quality of life
Evaluated according to the validated 15D© health related survey from adequately oriented subjects.
Time frame: 0 weeks, 16 weeks
Change in levels of other intestinal pathogens than C. difficile
Quantified from faecal samples
Time frame: 0 weeks, 8 weeks, 16 weeks
Change in bowel function
Assessed according to Bristol Stool Form Scale by health care personnel throughout the study
Time frame: 0 weeks, 16 weeks
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