Trials / Completed
CompletedNCT01475942
Probiotic Intervention With Elderly Subjects
Randomized Placebo Controlled Study to Assess the Effect of a Probiotic Supplement on the Subclinical Levels of Intestinal C. Difficile Among Elderly
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Danisco · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
Summary
The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile levels of elderly subjects.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Probiotic | 4 month probiotic intervention with 1 month run-in and 1 month wash-out. Probiotic given once a day. |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2011-11-22
- Last updated
- 2016-01-27
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT01475942. Inclusion in this directory is not an endorsement.