Probiotic Intervention With Elderly Subjects

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01475942

Enrollment

104

Registered

2011-11-22

Start date

2011-01-31

Completion date

2013-06-30

Last updated

2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal C. Difficile

Keywords

elderly, probiotic, bowel function, pathogen, constipation, diarrhoea, Subclinical levels

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTProbiotic

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change in level of faecal Clostridium difficile	0 weeks, 8 weeks, 16 weeks	Quantification of C. difficile from faecal samples

Secondary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026