Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000429257
Ethics application status
Approved
Date submitted
5/04/2009
Date registered
10/06/2009
Date last updated
5/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Probiotic treatment for the prevention of antibiotic-associated diarrhea in geriatric patients.
Scientific title
Probiotics (Lactobacillus casei Shirota strain, Yakult) for the prevention of antibiotic-associated diarrhea in geriatric patients admitted to subacute units.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diarrhea 4565 0
Condition category
Condition code
Oral and Gastrointestinal 4858 4858 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of 65mL probiotic drink containing Lactobacillus casei Shirota strain twice a day everyday during the participant's admission (average length of stay is 25days).
Intervention code [1] 4328 0
Prevention
Comparator / control treatment
Placebo- same 65mL drink without the active probiotic strain administered twice a day everyday during their admission (average length of admission is 25 days).
Control group
Placebo

Outcomes
Primary outcome [1] 5712 0
Diarrhea defined as three or more bowel motions of type 6 or 7 consistency as defined by the Bristol Stool Chart during a 24 hr period for 2 consecutive days.
Timepoint [1] 5712 0
During the participant's admission to the subacute ward their bowel motions will be recorded at least three times a day (once each nursing shift). The bowel chart will be audited on multiple occasions during their admission and all documented bowel motions will be reviewed.
Secondary outcome [1] 241631 0
nil
Timepoint [1] 241631 0
n/a

Eligibility
Key inclusion criteria
All consented participants admitted to a subacute 'geriatric evaluation and management' bed at St Vincent's and St George's hospital during the trial period.
Minimum age
65 Years
Maximum age
105 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes participants who have had recent bowel surgery, history of an artificial heart valve or rheumatic heart disease, previous infective endocarditis, artificial feeding via a nasogastric tube, severe life threatening illness, immunosuppression or intolerance to cow milk protein and citrus intolerance.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1579 0
3065

Funding & Sponsors
Funding source category [1] 4753 0
Hospital
Name [1] 4753 0
St Vincent's Health, Victoria
Country [1] 4753 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Health
Address
41 Victoria Parade
Fitzroy
Victoria
3065
Country
Australia
Secondary sponsor category [1] 4292 0
None
Name [1] 4292 0
n/a
Address [1] 4292 0
n/a
Country [1] 4292 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6796 0
Research and Grants Unit
St Vincent's Hospital
Ethics committee address [1] 6796 0
41 Victoria Parade
Fitzroy Victoria 3065
Ethics committee country [1] 6796 0
Australia
Date submitted for ethics approval [1] 6796 0
24/04/2009
Approval date [1] 6796 0
29/06/2009
Ethics approval number [1] 6796 0
HREC-A 048/09

Summary
Brief summary
We plan a randomised controlled double blinded trial to answer the question; does the regular use of a commercially available probiotic (Yakult) reduce the incidence and duration of diarrhea amongst geriatric inpatients (people aged =65yo)? The study population is all patients admitted to the sub-acute wards of St Vincent’s Hospital and St George’s Hospital during the period of the study. Recent antibiotic use in the last 2-8 weeks can commonly cause the complication of diarrhea. This can extend inpatient stay by 3-7 days, increase morbidity including dehydration and deconditioning due to illness, increase mortality by 2-3 times and cause hospital outbreaks of diarrhea in the general hospitalised population. The geriatric population admitted to subacute wards are frailer and have multiple co-morbidities. They have a higher incidence of recent antibiotic use and increased risk of complications developing secondary to diarrhea.

All patients admitted to the subacute wards who meet the inclusion criteria will be invited to participate. They will be encouraged to drink the 65ml milk product twice a day which will be randomised as to whether it contains the probiotic. Basic demographic data will be collected from the patient chart including age, gender, medical co-morbidities, recent antibiotic use, and current medications. The patient bowel charts will be monitored to ascertain the incidence of diarrhea.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29465 0
Address 29465 0
Country 29465 0
Phone 29465 0
Fax 29465 0
Email 29465 0
Contact person for public queries
Name 12712 0
Dr Kelly Wright
Address 12712 0
c/-Geriatric Department
St George's Hospital
283 Cotham Rd
Kew
Victoria 3101
Country 12712 0
Australia
Phone 12712 0
+ 61 3 83451212
Fax 12712 0
Email 12712 0
[email protected]
Contact person for scientific queries
Name 3640 0
Dr Kelly Wright
Address 3640 0
c/- Geriatric Department
St George's Hospital
283 Cotham Rd
Kew
Victoria 3101
Country 3640 0
Australia
Phone 3640 0
+61 3 83451212
Fax 3640 0
+61 3 8345 1449
Email 3640 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProbiotic treatment for the prevention of antibiotic-associated diarrhoea in geriatric patients: a multicentre randomised controlled pilot study.2015https://dx.doi.org/10.1111/ajag.12116
N.B. These documents automatically identified may not have been verified by the study sponsor.