Probiotic Intervention With Elderly Subjects

Phase 2

Completed

• Conditions: Intestinal C. Difficile
• Interventions: Dietary Supplement: Probiotic

• Registration Number: NCT01475942
• Lead Sponsor: Danisco

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-22
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-02
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Lactobacillus
Placebo	Probiotic	Sucrose

Primary Outcome Measures

Name	Time	Method
Change in level of faecal Clostridium difficile	0 weeks, 8 weeks, 16 weeks	Quantification of C. difficile from faecal samples

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Elderly Home Kerttuli; 🇫🇮 Turku, Finland