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Probiotic Intervention With Elderly Subjects

This study has been completed.
University of Turku
Information provided by (Responsible Party):
Danisco Identifier:
First received: September 20, 2011
Last updated: January 26, 2016
Last verified: February 2015
The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile levels of elderly subjects.

Condition Intervention Phase
Intestinal C. Difficile
Dietary Supplement: Probiotic
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Placebo Controlled Study to Assess the Effect of a Probiotic Supplement on the Subclinical Levels of Intestinal C. Difficile Among Elderly

Resource links provided by NLM:

Further study details as provided by Danisco:

Primary Outcome Measures:
  • Change in level of faecal Clostridium difficile [ Time Frame: 0 weeks, 8 weeks, 16 weeks ]
    Quantification of C. difficile from faecal samples

Secondary Outcome Measures:
  • Change in nutritional status [ Time Frame: 0 weeks, 16 weeks ]
    Evaluated according to the Mini Nutritional Assessment (MNA®) questionnaire.

  • Change in quality of life [ Time Frame: 0 weeks, 16 weeks ]
    Evaluated according to the validated 15D© health related survey from adequately oriented subjects.

  • Change in levels of other intestinal pathogens than C. difficile [ Time Frame: 0 weeks, 8 weeks, 16 weeks ]
    Quantified from faecal samples

  • Change in bowel function [ Time Frame: 0 weeks, 16 weeks ]
    Assessed according to Bristol Stool Form Scale by health care personnel throughout the study

Enrollment: 104
Study Start Date: January 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotic
Dietary Supplement: Probiotic
4 month probiotic intervention with 1 month run-in and 1 month wash-out. Probiotic given once a day.
Other Name: Lactobacillus
Placebo Comparator: Placebo
Dietary Supplement: Probiotic
4 month probiotic intervention with 1 month run-in and 1 month wash-out. Probiotic given once a day.
Other Name: Lactobacillus

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.

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01475942

Elderly Home Kerttuli
Turku, Finland
Sponsors and Collaborators
University of Turku
Study Chair: Sampo Lahtinen, PhD Danisco
Study Director: Anna Lyra, PhD Danisco
Principal Investigator: Matti Viitanen, MD University of Turku
  More Information

Responsible Party: Danisco Identifier: NCT01475942     History of Changes
Other Study ID Numbers: Turku_elderly
Study First Received: September 20, 2011
Last Updated: January 26, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Danisco:
bowel function
Subclinical levels processed this record on April 28, 2017