ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

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]

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]

nil

Timepoint [1]

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?

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]

3065

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Health, Victoria

Address [1]

41 Victoria Parade
Fitzroy
Victoria
3065

Country [1]

Australia

Primary sponsor type

Hospital

Name

St Vincent's Health

Address

41 Victoria Parade
Fitzroy
Victoria
3065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

n/a

Address [1]

n/a

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research and Grants Unit
St Vincent's Hospital

Ethics committee address [1]

41 Victoria Parade
Fitzroy Victoria 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/04/2009

Approval date [1]

29/06/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Kelly Wright

Address

c/-Geriatric Department
St George's Hospital
283 Cotham Rd
Kew
Victoria 3101

Country

Australia

Phone

+ 61 3 83451212

Fax

kelly.j.wright@mh.org.au

Contact person for scientific queries

Name

Dr Kelly Wright

Address

c/- Geriatric Department
St George's Hospital
283 Cotham Rd
Kew
Victoria 3101

Country

Australia

Phone

+61 3 83451212

Fax

+61 3 8345 1449

kelly.j.wright@mh.org.au

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

Source	Title	Year of Publication	DOI
Embase	Probiotic treatment for the prevention of antibiotic-associated diarrhoea in geriatric patients: a multicentre randomised controlled pilot study.	2015	https://dx.doi.org/10.1111/ajag.12116

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically