DiarrheaPROAGENCT00794924
Probiotics and Hospital Outcome in the Elderly
A study testing VSL#3 in people with Diarrhea and Constipation, run by Kaplan-Harzfeld Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diarrhea, Constipation
- What is being tested?
- VSL#3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 345 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Jan 2005
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who were hospitalized in the Department of Geriatric Orthopedic Rehabilitation a week before their enrollment in the study and signed an informed consent.
Who cannot join
- Known or suspected allergy to any probiotics
- Neutropenia
- Inability to sign an informed consent
About this study
Official title: Effects of Commercially Available Probiotics on Hospital Outcome
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.
Read the detailed 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.
- Conditions
- Diarrhea, Constipation
- Being tested
- VSL#3, placebo
- Keywords
- probiotics, elderly, motility, diarrhea
- Medical subject headings
- Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Dietary supplement
Also called probiotics, VSL phrma,USA
one sachet per day, for 45 consecutive days
placeboDietary supplement
one sachet per day, for 45 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Probiotics, VSL#3 | Experimental | Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days. Receives: Dietary Supplement: VSL#3 |
| Placebo | Placebo comparator | Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days. Receives: Dietary Supplement: VSL#3; Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 days of measuring the outcome
Secondary outcomes (1)
Improvement in Nutritional and Immunological Measurements
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startFeb 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaplan-Harzfeld Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Hilla Zahroni, MA, Principal investigator, Chief dietician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794924
- Sponsor's protocol ID
- Probiotics and elderly
- Acronym
- PROAGE
- Status last verified
- Nov 2008
- First submitted
- 28 Oct 2008
- Last updated
- 20 Nov 2008
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21369670
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Commercially Available Probiotics on Hospital Outcome
- ClinicalTrials.gov ID
- NCT00794924
- Acronym / sponsor ID
- PROAGE / Probiotics and elderly
- Conditions
- Diarrhea, Constipation
- Keywords
- probiotics, elderly, motility, diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Kaplan-Harzfeld Medical CenterUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 20 Nov 2008 (estimated)
- Results
- Posted 20 Nov 2008
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics, VSL#3 | Experimental | Dietary Supplement: VSL#3Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days. |
| Placebo | Placebo comparator | Dietary Supplement: VSL#3, Dietary Supplement: placeboAcutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were hospitalized in the Department of Geriatric Orthopedic Rehabilitation a week before their enrollment in the study and signed an informed consent.
Key exclusion criteria (3 listed)
- Known or suspected allergy to any probiotics
- Neutropenia
- Inability to sign an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSL#3Also: probiotics, VSL phrma,USAone sachet per day, for 45 consecutive days | Dietary supplement | Placebo, Probiotics, VSL#3 |
| placeboone sachet per day, for 45 consecutive days | Dietary supplement | Placebo |
Primary outcome
Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group
Time frame: 45 days of measuring the outcome
Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea.
1 secondary outcome
Improvement in Nutritional and Immunological Measurements
Time frame: 45 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2008.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21369670Zaharoni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilla Zahroni, MA principal investigator
Chief dietician
Questions about this trial
What is this clinical trial studying?
A study testing VSL#3 in people with Diarrhea and Constipation, run by Kaplan-Harzfeld Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group (time frame: 45 days of measuring the outcome). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00794924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2008.