Clostridium Difficile, Elderly, Fecal Metabolome, Gut Microbiota, Probiotics
Conditions
Brief summary
The study is randomized, double-blinded and placebo-controlled with a duration of 24 weeks. Following randomization, healthy elderly are randomized into two groups receiving probiotics or placebo. Fecal samples are collected before and after the study. The samples are investigated for Clostridium difficile levels, changes in diversity of the gut microbiota as well changes in the fecal metabolome. The effects of the produced metabolites on mitochondrial activity will moreover be investigated using selected intestinal cell lines.
Interventions
DIETARY_SUPPLEMENTHOWARU Restore
Sponsors
Gabriella C. van Zanten
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy * aged 75 years or more
Exclusion criteria
* Individuals with chronic bowel diseases * Individuals with severe immunosuppression * Individuals with dementia * Individuals who are terminally ill * If severe/prolonged illness occurs after the start of the test, the subject must drop out of the study * Individuals who have consumed probiotic products after two weeks prior to the start of the study or during it. * Subjects with a history of substance abuse * Subjects that, in the investigators opinion, are not expected to complete the study succesfully
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal Clostridium difficile numbers | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| fecal microbial composition | 24 weeks |
Other
| Measure | Time frame |
|---|---|
| fecal metabolome | 24 weeks |
Countries
Denmark
Outcome results
None listed