Probiotics and Hospital Outcome in the Elderly (PROAGE)

Kaplan-Harzfeld Medical Center

Status: Completed

Conditions: Diarrhea; Constipation

Treatments: Dietary Supplement: VSL#3; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00794924

Probiotics and elderly

Details and patient eligibility

About

Probiotics have been shown to reduce the rate of diarrhea and constipation. The purpose of this study was to investigate if probiotics could improve outcome of hospitalized orthopedic elderly patients.

Full description

The patients were divided into two groups. One received probiotics for 45 days and the second received placebo. The patients had a clinical and epidemiological as well as nutritional assessment. They were followed-up as for their bowel movements, abdominal pain and nosocomial infections and for the incidence of helicobacter pylori and clostridiume difficille diarrhea.

Enrollment: 345 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who were hospitalized in the Department of Geriatric Orthopedic Rehabilitation a week before their enrollment in the study and signed an informed consent.

Exclusion criteria

• Known or suspected allergy to any probiotics
• Neutropenia
• Inability to sign an informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

345 participants in 2 patient groups, including a placebo group

Probiotics, VSL#3

Experimental group

Description:

Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.

Treatment:

Dietary Supplement: VSL#3

Placebo

Placebo Comparator group

Description:

Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.

Treatment:

Dietary Supplement: placebo

Dietary Supplement: VSL#3