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Probiotic Intervention With Elderly Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Turku
Information provided by (Responsible Party):
Danisco
ClinicalTrials.gov Identifier:
NCT01475942
First received: September 20, 2011
Last updated: November 13, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    Quantification of C. difficile from faecal samples


Secondary Outcome Measures:
  • Change in nutritional status [ Time Frame: 0 weeks, 16 weeks ] [ Designated as safety issue: No ]
    Evaluated according to the Mini Nutritional Assessment (MNA®) questionnaire.

  • Change in quality of life [ Time Frame: 0 weeks, 16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quantified from faecal samples

  • Change in bowel function [ Time Frame: 0 weeks, 16 weeks ] [ Designated as safety issue: No ]
    Assessed according to Bristol Stool Form Scale by health care personnel throughout the study


Estimated Enrollment: 112
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated 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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study Director: Anneli Tarpila, PhD Danisco
Principal Investigator: Matti Viitanen, MD Turku University
  More Information

No publications provided

Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT01475942     History of Changes
Other Study ID Numbers: Turku_elderly
Study First Received: September 20, 2011
Last Updated: November 13, 2012
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on May 21, 2013