Probiotic Intervention With Elderly Subjects

NCT ID: NCT01475942

Last Updated: 2016-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Intestinal C. Difficile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

Lactobacillus

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Sucrose

Group Type PLACEBO_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Probiotic

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Lactobacillus

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role collaborator

Danisco

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sampo Lahtinen, PhD

Role: STUDY_CHAIR

Danisco

Anna Lyra, PhD

Role: STUDY_DIRECTOR

Danisco

Matti Viitanen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Turku

Locations

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Elderly Home Kerttuli

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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Turku_elderly

Identifier Type: -

Identifier Source: org_study_id

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