Trials / Completed
CompletedNCT02207140
Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Gabriella C. van Zanten · Academic / Other
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | HOWARU Restore |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2014-08-04
- Last updated
- 2016-06-21
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT02207140. Inclusion in this directory is not an endorsement.