Probiotic Intervention With Elderly Subjects

Study Overview
=================
Brief 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.

Official Title
-----------------
Randomized Placebo Controlled Study to Assess the Effect of a Probiotic Supplement on the Subclinical Levels of Intestinal C. Difficile Among Elderly

Conditions
-----------------
Intestinal C. Difficile

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elderly subjects no acute infection at recruitment Exclusion Criteria: antibiotic treatment 1 month prior to beginning of study less than 6 month life expectancy

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>Lactobacillus | Dietary Supplement: Probiotic<br>* 4 month probiotic intervention with 1 month run-in and 1 month wash-out. Probiotic given once a day.<br>* Other names: Lactobacillus;|
| Placebo Comparator: Placebo<br>Sucrose | Dietary Supplement: Probiotic<br>* 4 month probiotic intervention with 1 month run-in and 1 month wash-out. Probiotic given once a day.<br>* Other names: Lactobacillus;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of faecal Clostridium difficile | Quantification of C. difficile from faecal samples | 0 weeks, 8 weeks, 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nutritional status | Evaluated according to the Mini Nutritional Assessment (MNA®) questionnaire. | 0 weeks, 16 weeks | 
| Change in quality of life | Evaluated according to the validated 15D© health related survey from adequately oriented subjects. | 0 weeks, 16 weeks | 
| Change in levels of other intestinal pathogens than C. difficile | Quantified from faecal samples | 0 weeks, 8 weeks, 16 weeks | 
| Change in bowel function | Assessed according to Bristol Stool Form Scale by health care personnel throughout the study | 0 weeks, 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, probiotic, bowel function, pathogen, constipation, diarrhoea, Subclinical levels