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Probiotic Intervention With Elderly Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01475942
First Posted: November 22, 2011
Last Update Posted: January 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Turku
Information provided by (Responsible Party):
Danisco
  Purpose
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: Quadruple (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
Lactobacillus
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
Sucrose
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475942


Locations
Finland
Elderly Home Kerttuli
Turku, Finland
Sponsors and Collaborators
Danisco
University of Turku
Investigators
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
ClinicalTrials.gov Identifier: NCT01475942     History of Changes
Other Study ID Numbers: Turku_elderly
First Submitted: September 20, 2011
First Posted: November 22, 2011
Last Update Posted: January 27, 2016
Last Verified: February 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Danisco:
elderly
probiotic
bowel function
pathogen
constipation
diarrhoea
Subclinical levels