NCT00794924

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2008

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 20, 2008

Completed
Same day until next milestone

Results Posted

Study results publicly available

November 20, 2008

Completed
Last Updated

November 20, 2008

Status Verified

November 1, 2008

Enrollment Period

11 months

First QC Date

October 28, 2008

Results QC Date

October 28, 2008

Last Update Submit

November 19, 2008

Conditions

DiarrheaConstipation

Keywords

probioticselderlymotilitydiarrhea

Outcome Measures

Primary Outcomes (1)

  • Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group

    Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea.

    45 days of measuring the outcome

Secondary Outcomes (1)

  • Improvement in Nutritional and Immunological Measurements

    45 days

Study Arms (2)

Probiotics, VSL#3

EXPERIMENTAL

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

Dietary Supplement: VSL#3

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: VSL#3Dietary Supplement: placebo

Interventions

VSL#3DIETARY_SUPPLEMENT

one sachet per day, for 45 consecutive days

Also known as: probiotics, VSL phrma,USA
PlaceboProbiotics, VSL#3
placeboDIETARY_SUPPLEMENT

one sachet per day, for 45 consecutive days

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zaharoni H, Rimon E, Vardi H, Friger M, Bolotin A, Shahar DR. Probiotics improve bowel movements in hospitalized elderly patients--the PROAGE study. J Nutr Health Aging. 2011 Mar;15(3):215-20. doi: 10.1007/s12603-010-0323-3.

    PMID: 21369670DERIVED

MeSH Terms

Conditions

DiarrheaConstipation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Hilla Zaharoni
Organization
Kaplan-Harzfeld Geriatric Medical Center
hilla_z@clalit.org.il
97288595350

Study Officials

  • Hilla Zahroni, MA

    Chief dietician

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 28, 2008

First Posted

November 20, 2008

Study Start

February 1, 2004

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

November 20, 2008

Results First Posted

November 20, 2008

Record last verified: 2008-11