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Completed

NCT Number: NCT01475942

Probiotic Intervention With Elderly Subjects

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

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Key information

Conditions

Intestinal C. Difficile Constipation Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Elderly Home Kerttuli

Turku, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

4 month probiotic intervention with 1 month run-in and 1 month wash-out. Probiotic given once a day.

Other names: Lactobacillus

Primary outcomes

  1. Change in level of faecal Clostridium difficile

    Time frame: 0 weeks, 8 weeks, 16 weeks

    Quantification of C. difficile from faecal samples

Secondary outcomes

  1. Change in nutritional status

    Time frame: 0 weeks, 16 weeks

    Evaluated according to the Mini Nutritional Assessment (MNA®) questionnaire.

  2. Change in quality of life

    Time frame: 0 weeks, 16 weeks

    Evaluated according to the validated 15D© health related survey from adequately oriented subjects.

  3. Change in levels of other intestinal pathogens than C. difficile

    Time frame: 0 weeks, 8 weeks, 16 weeks

    Quantified from faecal samples

  4. Change in bowel function

    Time frame: 0 weeks, 16 weeks

    Assessed according to Bristol Stool Form Scale by health care personnel throughout the study

Sponsors and collaborators

Lead sponsor

Danisco

Industry

Collaborators

  • University of Turku

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 22, 2011
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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