Probiotic Intervention With Elderly Subjects

January 26, 2016 updated by: Danisco

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

The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile levels of elderly subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Elderly Home Kerttuli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Lactobacillus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in level of faecal Clostridium difficile
Time Frame: 0 weeks, 8 weeks, 16 weeks
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
Time Frame: 0 weeks, 16 weeks
Evaluated according to the Mini Nutritional Assessment (MNA®) questionnaire.
0 weeks, 16 weeks
Change in quality of life
Time Frame: 0 weeks, 16 weeks
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
Time Frame: 0 weeks, 8 weeks, 16 weeks
Quantified from faecal samples
0 weeks, 8 weeks, 16 weeks
Change in bowel function
Time Frame: 0 weeks, 16 weeks
Assessed according to Bristol Stool Form Scale by health care personnel throughout the study
0 weeks, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danisco

Collaborators

University of Turku

Investigators

  • Principal Investigator: Matti Viitanen, MD, University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Turku_elderly

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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