Probiotic Intervention With Elderly Subjects

Danisco

Status and phase: Completed; Phase 2

Conditions: Intestinal C. Difficile

Treatments: Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01475942

Turku_elderly

Details and patient eligibility

About

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

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

Lactobacillus

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

Sucrose

Treatment:

Dietary Supplement: Probiotic